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1.  Knowledge and information needs of young people with epilepsy and their parents: Mixed-method systematic review 
BMC Pediatrics  2010;10:103.
Background
Young people with neurological impairments such as epilepsy are known to receive less adequate services compared to young people with other long-term conditions. The time (age 13-19 years) around transition to adult services is particularly important in facilitating young people's self-care and ongoing management. There are epilepsy specific, biological and psycho-social factors that act as barriers and enablers to information exchange and nurturing of self-care practices. Review objectives were to identify what is known to be effective in delivering information to young people age 13-19 years with epilepsy and their parents, to describe their experiences of information exchange in healthcare contexts, and to identify factors influencing positive and negative healthcare communication.
Methods
The Evidence for Policy and Practice Information Coordinating Centre systematic mixed-method approach was adapted to locate, appraise, extract and synthesise evidence. We used Ley's cognitive hypothetical model of communication and subsequently developed a theoretical framework explaining information exchange in healthcare contexts.
Results
Young people and parents believed that healthcare professionals were only interested in medical management. Young people felt that discussions about their epilepsy primarily occurred between professionals and parents. Epilepsy information that young people obtained from parents or from their own efforts increased the risk of epilepsy misconceptions. Accurate epilepsy knowledge aided psychosocial adjustment. There is some evidence that interventions, when delivered in a structured psycho-educational, age appropriate way, increased young people's epilepsy knowledge, with positive trend to improving quality of life. We used mainly qualitative and mixed-method evidence to develop a theoretical framework explaining information exchange in clinical encounters.
Conclusions
There is a paucity of evidence reporting effective interventions, and the most effective ways of delivering information/education in healthcare contexts. No studies indicated if improvement was sustained over time and whether increased knowledge was effective in improving in self-care. Current models of facilitating information exchange and self-care around transition are not working well. There is an urgent need for further studies to develop and evaluate interventions to facilitate successful information exchange, and follow young people over time to see if interventions showing early promise are effective in the medium to long-term.
doi:10.1186/1471-2431-10-103
PMCID: PMC3022792  PMID: 21194484
2.  Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project 
BMC Pediatrics  2010;10:101.
Background
Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.
Methods/Design
This randomised controlled trial (RCT) is being conducted with 198 children (aged between 5 to 12 years) with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist), focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV). Secondary outcomes are child sleep (actigraphy and parent report), behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview) on treatment outcome.
Discussion
To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD symptoms in this patient group.
Trial Registration
Current Controlled Trials ISRCTN68819261.
ISRCTN: ISRCTN68819261
doi:10.1186/1471-2431-10-101
PMCID: PMC3022790  PMID: 21192797
3.  Children from Baffin Island have a disproportionate burden of tuberculosis in Canada: data from the Children's Hospital of Eastern Ontario (1998-2008) 
BMC Pediatrics  2010;10:102.
Background
The Children's Hospital of Eastern Ontario (CHEO) provides services to children in Baffin Island, through the Baffin Island Pediatric Health Initiative. Tuberculosis (TB) remains a major public health problem in that region. The objective of our study was to describe the origin and clinical characteristics of patients with TB disease at CHEO, since the inception of the Baffin Island Pediatric Health Initiative.
Methods
All charts with a discharge diagnosis of TB disease during the first 10 years of the Baffin Island program were reviewed. Patients meeting a pre-determined case definition were included in analyses. A standard medical record abstraction form was used for patient data collection.
Results
Twenty patients met our case definition. Seven (35%) were Canadian-born children from Baffin Island. Seven resided in Ontario, 4 in Quebec, and 2 were visiting from other countries. All 7 children residing in Ontario were born in African countries. Endothoracic disease occurred in 16 patients (80%), including 9 with primary pulmonary TB, and 3 with sputum smear positive "adult-type" disease. Extrathoracic disease was present in 6 children (30%), including 3 with CNS disease. Three children had disease in 2 separate sites.
Conclusions
While Baffin Island makes up 1% of the hospital catchment population, they contributed 35% of TB patients, and the only TB death. While TB in foreign-born children is due in part to epidemics abroad, the problem in Baffin Island is a reflection of disease burden and transmission within Canada.
doi:10.1186/1471-2431-10-102
PMCID: PMC3022791  PMID: 21192806
4.  Nasal Carriage and Antimicrobial Susceptibility of Staphylococcus aureus in healthy preschool children in Ujjain, India 
BMC Pediatrics  2010;10:100.
Background
There is increasing evidence that community acquired S. aureus infections are spreading among healthy children. Nasal colonization with S. aureus plays pivotal role in the increasing prevalence of resistant community acquired S. aureus infections worldwide. A regular surveillance system is important in ensuring quality of patient care. The aim of the study was to assess the prevalence of and the factors associated with nasal carriage of S. aureus and its antibiotic sensitivity pattern among healthy children in Ujjain, India.
Methods
A prospective study was done in paediatric outpatient clinics of R.D. Gardi medical college Ujjain, India. Healthy children from 1 month to 59 months of age were included. Information on previously known risk factors for nasal colonization was collected using a pre-tested questionnaire. Swabs from anterior nares were collected and transported in Amies transport media with charcoal and cultured on 5% sheep blood agar. Antibiotic sensitivity tests were performed using Kirby Bauer's disc diffusion method according to performance standards of Clinical and Laboratory Standard Institute guidelines.
Results
Of the 1,562 children from 1-month up-to five years of age included in the study 98 children tested positive for nasal carriage of S. aureus. The prevalence of nasal carriage of S. aureus was 6.3% (95% CI 5.1-7.5) out of which 16.3% (95% CI 8.9-23.8) were methicillin-resistant S. aureus (MRSA). The factors associated with nasal carriage were "child attending preschool" (OR 4.26, 95% CI 2.25-8.03; P = 0.007) or "school" (OR 3.02, 95% CI 1.27-7.18; P < 0.001) and "family size more than 10 members" (OR 2.76 95% CI 1.06-7.15; P = 0.03). The sensitivity pattern of isolated S. aureus showed resistance to commonly used oral antibiotics while resistance to glycopeptides was not noted.
Conclusions
We found a relatively low rate of nasal carriage of S. aureus in children below five years when compared to children of older age groups in India. Yet, prevalence of MRSA was relatively high.
doi:10.1186/1471-2431-10-100
PMCID: PMC3022789  PMID: 21190550
5.  Cognitive and psychosocial development of HIV pediatric patients receiving highly active anti-retroviral therapy: a case-control study 
BMC Pediatrics  2010;10:99.
Background
The psychosocial development of pediatric HIV patients has not been extensively evaluated. The study objectives were to evaluate whether emotional and social functions are differentially associated with HIV-related complications.
Methods
A matched case-control study design was conducted. The case group (n = 20) consisted of vertically infected children with HIV (aged 3-18 years) receiving HAART in Greece. Each case was matched with two randomly selected healthy controls from a school-based population. CNS imaging and clinical findings were used to identify patients with HIV-related neuroimaging abnormalities. The Wechsler Intelligence Scale III and Griffiths Mental Abilities Scales were applied to assess cognitive abilities. The age specific Strengths and Difficulties Questionnaire was used to evaluate emotional adjustment and social skills. The Fisher's exact test, student's t-test, and Wilcoxon rank sum test were used to compare categorical, continuous, and ordinal scores, respectively, of the above scales between groups.
Results
HIV patients without neuroimaging abnormalities did not differ from patients with neuroimaging abnormalities with respect to either age at HAART initiation (p = 0.306) or months of HAART treatment (p = 0.964). While HIV patients without neuroimaging abnormalities had similar cognitive development with their healthy peers, patients with neuroimaging abnormalities had lower mean General (p = 0.027) and Practical (p = 0.042) Intelligence Quotient scores. HIV patients without neuroimaging abnormalities had an increased likelihood of both Abnormal Emotional Symptoms (p = 0.047) and Hyperactivity scores (p = 0.0009). In contrast, HIV patients with neuroimaging abnormalities had an increased likelihood of presenting with Abnormal Peer Problems (p = 0.033).
Conclusions
HIV patients without neuroimaging abnormalities are more likely to experience maladjustment with respect to their emotional and activity spheres, while HIV patients with neuroimaging abnormalities are more likely to present with compromised social skills. Due to the limited sample size and age distribution of the study population, further studies should investigate the psychosocial development of pediatric HIV patients following the disclosure of their condition.
doi:10.1186/1471-2431-10-99
PMCID: PMC3022796  PMID: 21184692
6.  Reproducibility of different screening classifications in ultrasonography of the newborn hip 
BMC Pediatrics  2010;10:98.
Background
Ultrasonography of the hip has gained wide acceptance as a primary method for diagnosis, screening and treatment monitoring of developmental hip dysplasia in infants. The aim of the study was to examine the degree of concordance of two objective classifications of hip morphology and subjective parameters by three investigators with different levels of experience.
Methods
In 207 consecutive newborns (101 boys; 106 girls) the following parameters were assessed: bony roof angle (α-angle) and cartilage roof angle (β-angle) according to Graf's basic standard method, "femoral head coverage" (FHC) as described by Terjesen, shape of the bony roof and position of the cartilaginous roof. Both hips were measured twice by each investigator with a 7.5 MHz linear transducer (SONOLINE G60S® ultrasound system, SIEMENS, Erlangen, Germany).
Results
Mean kappa-coefficients for the subjective parameters shape of the bony roof (0.97) and position of the cartilaginous roof (1.0) demonstrated high intra-observer reproducibility. Best results were achieved for α-angle, followed by β-angle and finally FHC. With respect to limits of agreement, inter-observer reproducibility was calculated less precisely.
Conclusions
Higher measurement differences were evaluated more in objective scorings. Those variations were observed by every investigator irrespective of level of experience.
doi:10.1186/1471-2431-10-98
PMCID: PMC3022795  PMID: 21184670
7.  In search of quality evidence for lifestyle management and glycemic control in children and adolescents with type 2 diabetes: A systematic review 
BMC Pediatrics  2010;10:97.
Background
Our purpose was to evaluate the impact of lifestyle behavior modification on glycemic control among children and youth with clinically defined Type 2 Diabetes (T2D).
Methods
We conducted a systematic review of studies (randomized trials, quasi-experimental studies) evaluating lifestyle (diet and/or physical activity) modification and glycemic control (HbA1c). Our data sources included bibliographic databases (EMBASE, CINAHL®, Cochrane Library, Medline®, PASCAL, PsycINFO®, and Sociological Abstracts), manual reference search, and contact with study authors. Two reviewers independently selected studies that included any intervention targeting diet and/or physical activity alone or in combination as a means to reduce HbA1c in children and youth under the age of 18 with T2D.
Results
Our search strategy generated 4,572 citations. The majority of citations were not relevant to the study objective. One study met inclusion criteria. In this retrospective study, morbidly obese youth with T2D were treated with a very low carbohydrate diet. This single study received a quality index score of < 11, indicating poor study quality and thus limiting confidence in the study's conclusions.
Conclusions
There is no high quality evidence to suggest lifestyle modification improves either short- or long-term glycemic control in children and youth with T2D. Additional research is clearly warranted to define optimal lifestyle behaviour strategies for young people with T2D.
doi:10.1186/1471-2431-10-97
PMCID: PMC3016367  PMID: 21182791
8.  A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007 
BMC Pediatrics  2010;10:96.
Background
Randomized controlled trials (RCTs) are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results.
Methods
We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey.
Results
Most studies (83%) were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB) was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008). Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25). Among survey respondents (50% response rate), the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process.
Conclusions
More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.
doi:10.1186/1471-2431-10-96
PMCID: PMC3018376  PMID: 21176224
9.  Perception and management of fever in infants up to six months of age: A survey of US pediatricans 
BMC Pediatrics  2010;10:95.
Background
A fever is an increase in the body's temperature above normal. This study examined how US pediatricians perceive and manage fever generally versus fever occurring after vaccination in infants up to six months of age.
Methods
A web-based survey of 400 US pediatricians subscribing to the Physician Desk Reference was conducted in December 2008. Data were collected on the respondents' socio-demographics, number of years in practice, type of practice, their definition of fever severity in infants, and their recommendations for managing fever. Generalized Estimating Equations were used to estimate the odds of a pediatrician recommending an emergency room visit (ER) or a hospital admission, office visits, or other treatment option, as a function of infant's age, temperature, whether the infant has recently received a vaccine, and whether the fever was reported during or after office hours, adjusting for practice type and socio-demographic variables.
Results
On average, the 400 responding pediatricians' (64% were female, average age of 49 years, years in practice = 20 years) threshold for extremely serious fever was ≥39.5°C and ≥ 40.0°C for infants 0-2 month and >2-6 month of age respectively. Infants were more likely to be referred to an ER or hospital admission if they were ≤ 2 months of age (Odds Ratio [OR], 29.13; 95% Confidence interval [95% CI], 23.69-35.82) or >2-4 months old (OR 3.37; 95% CI 2.99-3.81) versus > 4 to 6 months old or if they had a temperature ≥ 40.0°C (OR 21.06; 95% CI 17.20-25.79) versus a temperature of 38.0-38.5°C. Fever after vaccination (OR 0.29; 95% CI 0.25-0.33) or reported during office hours (OR 0.17; 95% CI 0.15-0.20) were less likely to result in referral to ER or hospital admission.
Conclusion
Within this sample of US pediatricians, perception of the severity of fever in infants, as well as the response to infant fever are likely to depend on the infant's age. Recommendations for the management of fever in infants are likely to depend on fever severity level, the infant age, timing in relation to recent vaccination, and the time of day fever is reported. Our results indicate that US pediatricians are more concerned about general fever than fever following vaccination.
doi:10.1186/1471-2431-10-95
PMCID: PMC3022794  PMID: 21176190
10.  Epidemiology of rotavirus infection among young children with acute diarrhoea in Burkina Faso 
BMC Pediatrics  2010;10:94.
Background
In anticipation of vaccine introduction, we assessed epidemiology of rotavirus disease among children visiting medical centre due to acute diarrhoea in Ouagadougou, Burkina Faso.
Methods
Between November 2008 and February 2010, stool specimens from 447 children less than 5 years of age suffering from diarrhoea were tested for the presence of rotavirus by antigen detection using an immunochromatographic test. Sociodemographic, environmental and clinical factors were assessed during the study.
Results
Rotavirus antigen was detected in 151 (33.8%) of the patients. Most of the cases (94.2%) were in children < 24 months of age. Fever and vomiting were the symptoms most commonly reported in association with rotavirus diarrhoea and the patients were often hospitalized. Rotavirus-associated diarrhoea occurred mostly during the season from December to April (dry season). Rotavirus infection was significantly less frequent in breast-fed than among bottle-fed babies.
Conclusions
The results of this study underscore the need to control rotavirus infections among young children in Burkina Faso and may argue a decision on the introduction of rotavirus vaccine in Burkina Faso.
doi:10.1186/1471-2431-10-94
PMCID: PMC3013080  PMID: 21171984
11.  Barriers to implementation of the HIV guidelines in the IMCI algorithm among IMCI trained health workers in Zambia 
BMC Pediatrics  2010;10:93.
Background
Zambia adopted integrated management of Childhood illnesses (IMCI) in 1995 and a number of adaptations have been made to the generic WHO/UNICEF IMCI guidelines to better conform to Zambia's health service needs. One significant adaptation is the incorporation of HIV guidelines into the IMCI algorithm. Since 2004, health workers that have undergone IMCI case management training have also received training in HIV assessment. During initial follow-up visits in 11 districts 90 health workers were assessed in 2007 to determine their adherence to the IMCI algorithm. The assessment showed that 97% of the health workers assessed did not review or mention the HIV guidelines even though they had received HIV training as part of IMCI. This study aimed to explore reasons for non-adherence to HIV guidelines in the IMCI algorithm and make recommendations on how this can be improved.
Methods
Both quantitative and qualitative methods were used to collect information from eligible health workers. Forty (40) health workers were randomly selected from among those who received initial follow-up visits between March 2007 and January 2008. The health workers were selected from eight districts in four provinces of Zambia. Qualitative data was collected using Focus group discussion and key informant interviews
Results
83% of the respondents said they had no difficulties in following the HIV adapted IMCI guidelines. 17% said they had difficulties. Of those who admitted having difficulties (60%) had difficulties in HIV assessment. Interesting, prompting and focus group discussions revealed that most respondents actually had difficulties in HIV assessment but could not admit it readily. Some barriers that contributed to non-adherence to the guidelines included lack of time due to inadequate staffing, lack of privacy in the health facilities and HIV related stigma from both caregivers and health workers. Frequent use of guidelines and supervision appeared to re-enforce adherence to the guidelines.
Conclusion
The findings in this study suggest that training in HIV adapted IMCI guidelines is not sufficient to enable health workers to actually use their knowledge in their daily practice. Barriers may exist which prevent them from adhering to the guidelines. Addressing these barriers is critical in increasing the uptake of paediatric ART in Zambia
doi:10.1186/1471-2431-10-93
PMCID: PMC3023733  PMID: 21167016
12.  Behavioural symptoms of attention deficit/hyperactivity disorder in preterm and term children born small and appropriate for gestational age: A longitudinal study 
BMC Pediatrics  2010;10:91.
Background
It remains unclear whether it is more detrimental to be born too early or too small in relation to symptoms of attention deficit/hyperactivity disorder (ADHD). Thus, we tested whether preterm birth and small body size at birth adjusted for gestational age are independently associated with symptoms of ADHD in children.
Methods
A longitudinal regional birth cohort study comprising 1535 live-born infants between 03/15/1985 and 03/14/1986 admitted to the neonatal wards and 658 randomly recruited non-admitted infants, in Finland. The present study sample comprised 828 children followed up to 56 months. The association between birth status and parent-rated ADHD symptoms of the child was analysed with multiple linear and logistic regression analyses.
Results
Neither prematurity (birth < 37 weeks of gestation) nor lower gestational age was associated with ADHD symptoms. However, small for gestational age (SGA < -2 standard deviations [SD] below the mean for weight at birth) status and lower birth weight SD score were significantly, and independently of gestational age, associated with higher ADHD symptoms. Those born SGA, relative to those born AGA, were also 3.60-times more likely to have ADHD symptoms scores above the clinical cut-off. The associations were not confounded by factors implicated as risks for pregnancy and/or ADHD.
Conclusions
Intrauterine growth restriction, reflected in SGA status and lower birth weight, rather than prematurity or lower gestational age per se, may increase risk for symptoms of ADHD in young children.
doi:10.1186/1471-2431-10-91
PMCID: PMC3012665  PMID: 21159164
13.  Maternal education is associated with vaccination status of infants less than 6 months in Eastern Uganda: a cohort study 
BMC Pediatrics  2010;10:92.
Background
Despite provision of free childhood vaccinations, less than half of all Ugandan infants are fully vaccinated. This study compares women with some secondary schooling to those with only primary schooling with regard to their infants' vaccination status.
Methods
A community-based prospective cohort study conducted between January 2006 and May 2008 in which 696 pregnant women were followed up to 24 weeks post partum. Information was collected on the mothers' education and vaccination status of the infants.
Results
At 24 weeks, the following vaccinations had been received: bacille Calmette-Guérin (BCG): 92%; polio-1: 91%; Diphteria-Pertussis-Tetanus-Hepatitis B-Haemophilus Influenza b (DPT-HB-Hib) 3 and polio-3: 63%. About 51% of the infants were fully vaccinated (i.e., had received all the scheduled vaccinations: BCG, polio 0, polio 1, DPT-HB-Hib1, polio 2, DPT-HB-Hib 2, polio 3 and DPT-HB-Hib 3). Only 46% of the infants whose mothers' had 5-7 years of primary education had been fully vaccinated compared to 65% of the infants whose mothers' had some secondary education. Infants whose mothers had some secondary education were less likely to miss the DPT-HB-Hib-2 vaccine (RR: 0.5, 95% CI: 0.3, 0.8), Polio-2 (RR: 0.4, 95%CI: 0.3, 0.7), polio-3 (RR: 0.5, 95%CI: 0.4, 0.7) and DPT-HB-Hib-3 (RR: 0.5, 95%CI: 0.4, 0.7). Other factors showing some association with a reduced risk of missed vaccinations were delivery at a health facility (RR = 0.8; 95%CI: 0.7, 1.0) and use of a mosquito net (RR: 0.8; 95%CI: 0.7, 1.0).
Conclusion
Infants whose mothers had a secondary education were at least 50% less likely to miss scheduled vaccinations compared to those whose mothers only had primary education. Strategies for childhood vaccinations should specifically target women with low formal education.
doi:10.1186/1471-2431-10-92
PMCID: PMC3019133  PMID: 21159193
14.  Development of paediatric quality of inpatient care indicators for low-income countries - A Delphi study 
BMC Pediatrics  2010;10:90.
Background
Indicators of quality of care for children in hospitals in low-income countries have been proposed, but information on their perceived validity and acceptability is lacking.
Methods
Potential indicators representing structural and process aspects of care for six common conditions were selected from existing, largely qualitative WHO assessment tools and guidelines. We employed the Delphi technique, which combines expert opinion and existing scientific information, to assess their perceived validity and acceptability. Panels of experts, one representing an international panel and one a national (Kenyan) panel, were asked to rate the indicators over 3 rounds and 2 rounds respectively according to a variety of attributes.
Results
Based on a pre-specified consensus criteria most of the indicators presented to the experts were accepted: 112/137(82%) and 94/133(71%) for the international and local panels respectively. For the other indicators there was no consensus; none were rejected. Most indicators were rated highly on link to outcomes, reliability, relevance, actionability and priority but rated more poorly on feasibility of data collection under routine conditions. There was moderate to substantial agreement between the two panels of experts.
Conclusions
This Delphi study provided evidence for the perceived usefulness of most of a set of measures of quality of hospital care for children proposed for use in low-income countries. However, both international and local experts expressed concerns that data for many process-based indicators may not currently be available. The feasibility of widespread quality assessment and responsiveness of indicators to intervention should be examined as part of continued efforts to improve approaches to informative hospital quality assessment.
doi:10.1186/1471-2431-10-90
PMCID: PMC3022793  PMID: 21144065
15.  Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on Duration of antibiotic Therapy in suspected neonatal early-onset Sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study 
BMC Pediatrics  2010;10:89.
Background
Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with nonspecific symptoms are started on antibiotic treatment before the presence of sepsis has been proven. With our recently published single-centre intervention study we were able to show that Procalcitonin determinations allowed to shorten the duration of antibiotic therapy in newborns with suspected early-onset sepsis.
Methods/Design
The study is designed as randomized controlled international multicenter intervention trial on the efficacy and safety of Procalcitonin guided treatment. Term and near-term infants (gestational age ≥ 34 0/7 weeks) with suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy will be included. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the likelihood of infection (infection unlikely, possible, probable or proven). In the Procalcitonin group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive Procalcitonin values are within the normal range. Co-primary outcome measures are the duration of antibiotic therapy (superiority aspect of the trial) and the proportion of infants with a recurrence of infection requiring additional courses of antibiotic therapy and/or death in the first month of life (safety of study intervention, non-inferiority aspect of the trial). The number of infants to be included equals 800 per arm. With these numbers the power of the study to demonstrate superiority for duration of antibiotic therapy as well as non-inferiority regarding safety, i.e. excluding a disadvantage difference larger than 2% for the experimental arm, will both be greater than 80%.
Discussion
Benefit of the study is a possible limitation of unnecessary use of antibiotics. The results of our first study suggest that there is a low risk on discontinuing antibiotic treatment too early, resulting in the development of a neonatal infection with its morbidity and mortality.
Trial registration
This trial is registered in the U.S. National Institutes of Health's register, located at http://www.clinicaltrials.gov. (NCT00854932).
doi:10.1186/1471-2431-10-89
PMCID: PMC3016366  PMID: 21143869
16.  Frequency of 22q11.2 microdeletion in children with congenital heart defects in western poland 
BMC Pediatrics  2010;10:88.
Background
The 22q11.2 microdeletion syndrome (22q11.2 deletion syndrome -22q11.2DS) refers to congenital abnormalities, including primarily heart defects and facial dysmorphy, thymic hypoplasia, cleft palate and hypocalcaemia. Microdeletion within chromosomal region 22q11.2 constitutes the molecular basis of this syndrome. The 22q11.2 microdeletion syndrome occurs in 1/4000 births. The aim of this study was to determine the frequency of 22q11.2 microdeletion in 87 children suffering from a congenital heart defect (conotruncal or non-conotruncal) coexisting with at least one additional 22q11.2DS feature and to carry out 22q11.2 microdeletion testing of the deleted children's parents. We also attempted to identify the most frequent heart defects in both groups and phenotypic traits of patients with microdeletion to determine selection criteria for at risk patients.
Methods
The analysis of microdeletions was conducted using fluorescence in situ hybridization (FISH) on metaphase chromosomes and interphase nuclei isolated from venous peripheral blood cultures. A molecular probe (Tuple) specific to the HIRA (TUPLE1, DGCR1) region at 22q11 was used for the hybridisation.
Results
Microdeletions of 22q11.2 region were detected in 13 children with a congenital heart defect (14.94% of the examined group). Microdeletion of 22q11.2 occurred in 20% and 11.54% of the conotruncal and non-conotruncal groups respectively. Tetralogy of Fallot was the most frequent heart defect in the first group of children with 22q11.2 microdeletion, while ventricular septal defect and atrial septal defect/ventricular septal defect were most frequent in the second group. The microdeletion was also detected in one of the parents of the deleted child (6.25%) without congenital heart defect, but with slight dysmorphism. In the remaining children, 22q11.2 microdeletion originated de novo.
Conclusions
Patients with 22q11.2DS exhibit wide spectrum of phenotypic characteristics, ranging from discreet to quite strong. The deletion was inherited by one child. Our study suggests that screening for 22q11.2 microdeletion should be performed in children with conotruncal and non-conotruncal heart defects and with at least one typical feature of 22q11.2DS as well as in the deleted children's parents.
doi:10.1186/1471-2431-10-88
PMCID: PMC3016365  PMID: 21134246
17.  Socio-demographic and behavioural correlates of oral hygiene status and oral health related quality of life, the Limpopo - Arusha school health project (LASH): A cross-sectional study 
BMC Pediatrics  2010;10:87.
Background
Promoting oral health of adolescents is important for improvement of oral health globally. This study used baseline-data from LASH-project targeting secondary students to; 1) assess frequency of poor oral hygiene status and oral impacts on daily performances, OIDP, by socio-demographic and behavioural characteristics, 2) examine whether socio-economic and behavioural correlates of oral hygiene status and OIDP differed by gender and 3) examine whether socio-demographic disparity in oral health was explained by oral health-related behaviours.
Methods
Cross-sectional study was conducted in 2009 using one-stage cluster sampling design. Total of 2412 students (mean age 15.2 yr) completed self-administered questionnaires, whereas 1077 (mean age 14.9 yr) underwent dental-examination. Bivariate analyses were conducted using cross-tabulations and chi-square statistics. Multiple variable analyses were conducted using stepwise standardized logistic regression (SLR) with odds ratios and 95% Confidence intervals (CI).
Results
44.8% presented with fair to poor OHIS and 48.2% reported any OIDP. Older students, those from low socio-economic status families, had parents who couldn't afford dental care and had low educational-level reported oral impacts, poor oral hygiene, irregular toothbrushing, less dental attendance and fewer intakes of sugar-sweetened drinks more frequently than their counterparts. Stepwise logistic regression revealed that reporting any OIDP was independently associated with; older age-groups, parents do not afford dental care, smoking experience, no dental visits and fewer intakes of sugar-sweetened soft drinks. Behavioural factors accounted partly for association between low family SES and OIDP. Low family SES, no dental attendance and smoking experience were most important in males. Low family SES and fewer intakes of sugar-sweetened soft drinks were the most important correlates in females.
Socio-behavioural factors associated with higher odds ratios for poor OHIS were; older age, belonging to the poorest household category and having parents who did not afford dental care across both genders.
Conclusion
Disparities in oral hygiene status and OIDP existed in relation to age, affording dental care, smoking and intake of sugar sweetened soft drinks. Gender differences should be considered in intervention studies, and modifiable behaviours have some relevance in reducing social disparity in oral health.
doi:10.1186/1471-2431-10-87
PMCID: PMC3001697  PMID: 21118499
18.  Treatment and disease progression in a birth cohort of vertically HIV-1 infected children in Ukraine 
BMC Pediatrics  2010;10:85.
Background
Ukraine has the highest HIV prevalence (1.6%) and is facing the fastest growing epidemic in Europe. Our objective was to describe the clinical, immunological and virological characteristics, treatment and response in vertically HIV-infected children living in Ukraine and followed from birth.
Methods
The European Collaborative Study (ECS) is an ongoing cohort study, in which HIV-1 infected pregnant women are enrolled and followed in pregnancy, and their children prospectively followed from birth. ECS enrolment in Ukraine started in 2000 initially with three sites, increasing to seven sites by 2009.
Results
A total of 245 infected children were included in the cohort by April 2009, with a median age of 23 months at most recent follow-up; 33% (n = 77) had injecting drug using mothers and 85% (n = 209) were infected despite some use of antiretroviral prophylaxis for prevention of mother-to-child transmission. Fifty-five (22%) children had developed AIDS, at a median age of 10 months (IQR = 6-19). The most prevalent AIDS indicator disease was Pneumocystis jiroveci pneumonia (PCP). Twenty-seven (11%) children had died (median age, 6.2 months). Overall, 108 (44%) children had started highly active antiretroviral treatment (HAART), at a median 18 months of age; median HAART duration was 6.6 months to date. No child discontinued HAART and 92% (100/108) remained on their first-line HAART regimen to date. Among children with moderate/severe immunosuppression, 36% had not yet started HAART. Among children on HAART, 71% (69/97) had no evidence of immunosuppression at their most recent visit; the median reduction in HIV RNA was 4.69 log10 copies/mL over a median of 10 months treatment. From survival analysis, an estimated 94%, 84% and 81% of children will be alive and AIDS-free at 6, 12 and 18 months of age, respectively. However, survival increased significantly over time: estimated survival rates to 12 months of age were 87% for children born in 2000/03 versus 96% for those born in 2004/08.
Conclusion
One in five children had AIDS and one in ten had died. The half of children who received HAART has responded well and survival has significantly improved over time. Earlier diagnosis and prompt initiation of HAART remain key challenges.
doi:10.1186/1471-2431-10-85
PMCID: PMC2997768  PMID: 21092301
19.  Process evaluation of a school based physical activity related injury prevention programme using the RE-AIM framework 
BMC Pediatrics  2010;10:86.
Background
In general, only information regarding the effectiveness of an intervention programme is ever published. However, in recent years evaluating the translatability and feasibility of an intervention programme has become more important. Therefore, this paper presents the results of the evaluation of the iPlay programme aimed at preventing physical activity related injuries in primary school children.
Methods
The iPlay programme targeted injuries gained through physical activity, and consisted of a teacher's manual, informative newsletters and posters, a website, and set exercises to be carried out during physical education (PE) classes. In order to evaluate the iPlay programme for translatability and feasibility, teachers, children and parents who participated in the iPlay programme filled out a questionnaire
The objective of this study is to describe the results of the process-evaluation of the iPlay programme based on the five dimensions of the RE-AIM framework.
Results
The results showed that the participation rate of the children was 100% (reach). Nine percent of the schools who were invited to take part were willing to participate in the study (adoption rate). Teachers stated that they implemented the different elements of the programme partly as intended (implementation). The percentage of children and parents who followed the programme was less than expected. In addition, 52% of the teachers indicated that the current iPlay programme could become standard practice in their teaching routine (maintenance).
Conclusion
The iPlay programme is a first start in the prevention of physical activity related injuries in children, but further improvements need to be made to the programme on the basis of this process evaluation.
Trial registration
ISRCTN78846684; http://www.controlled-trials.com
doi:10.1186/1471-2431-10-86
PMCID: PMC3004886  PMID: 21092316
20.  Use of rifampin in persistent coagulase negative staphylococcal bacteremia in neonates 
BMC Pediatrics  2010;10:84.
Background
Coagulase negative staphylococci (CoNS) are the most common cause of neonatal sepsis in the Neonatal Intensive Care Unit (NICU). A minority of neonates does not respond to vancomycin therapy and develops persistent bacteremia, which may be treated with rifampin. We evaluated the use of rifampin in persistent CoNS bacteremia.
Methods
Retrospective study of 137 neonates with CoNS bacteremia during admission to a tertiary NICU between July 2006 and July 2009. Main outcome measures were total duration of bacteremia and the adequacy of vancomycin and rifampin therapy.
Results
137/1696 (8.0%) neonates developed a CoNS bacteremia. Eighteen were treated with rifampin because of persistent bacteremia (3 positive blood cultures at least 48 hours apart with clinical symptoms) or (a serious suspicion of) an intravascular thrombus. Duration of bacteremia prior to rifampin therapy (8.0 ± 3.6 days) was positively correlated (p < 0.001) to the total duration of bacteremia (10.3 ± 3.7 days). After starting rifampin therapy C-reactive protein (CRP) levels of all neonates declined and blood cultures became sterile after 2.3 ± 1.6 days. Vancomycin levels were not consistently measured in all neonates, resulting in late detection of subtherapeutic trough levels.
Conclusion
Rifampin may be effective in the treatment of persistent CoNS infections in neonates. Outcome may be improved by adequate monitoring of vancomycin trough levels.
doi:10.1186/1471-2431-10-84
PMCID: PMC2994847  PMID: 21092087
21.  Study protocol: safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491 
BMC Pediatrics  2010;10:83.
Background
Despite new therapeutic approaches have improved the prognosis of newborns with retinopathy of prematurity (ROP), an unfavourable structural and functional outcome still remains high. There is high pressure to develop new drugs to prevent and treat ROP. There is increasing enthusiasm for anti-VEGF drugs, but angiogenic inhibitors selective for abnormal blood vessels would be considered as an optimal treatment.
In an animal experimental model of proliferative retinopathy, we have recently demonstrated that the pharmacological blockade of beta-adrenoreceptors improves retinal neovascularization and blood retinal barrier breakdown consequent to hypoxia. The purpose of this study is to evaluate the propranolol administration in preterm newborns suffering from a precocious phase of ROP in terms of safety and efficacy in counteracting the progression of retinopathy.
Methods/Design
Preterm newborns (gestational age at birth lower than 32 weeks) with stage 2 ROP (zone II-III without plus) will be randomized, according to their gestational age, to receive propranolol added to standard treatment (treatment adopted by the ETROP Cooperative Group) or standard treatment alone. Propranolol will be administered until retinal vascularization will be completely developed, but not more than 90 days. Forty-four participants will be recruited into the study. To evaluate the safety of propranolol administration, cardiac and respiratory parameters will be continuously monitored. Blood samplings will be performed to check renal, liver and metabolic balance. To evaluate the efficacy of propranolol, the progression of the disease, the number of laser treatments or vitrectomies, the incidence of retinal detachment or blindness, will be evaluated by serial ophthalmologic examinations. Visual function will be evaluated by means of behavioural standardized tests.
Discussion
This pilot study is the first research that explores the possible therapeutic role of beta blockers in ROP. The objective of this research is highly ambitious: to find a treatment simple, inexpensive, well tolerated and with few adverse effects, able to counteract one of the major complications of the prematurity. Any favourable results of this research could open new perspectives and original scenarios about the treatment or the prevention of this and other proliferative retinopathies.
Trial Registration
Current Controlled Trials ISRCTN18523491; ClinicalTrials.gov Identifier NCT01079715; EudraCT Number 2010-018737-21
doi:10.1186/1471-2431-10-83
PMCID: PMC2993687  PMID: 21087499
22.  The first three years of screening for medium chain acyl-CoA dehydrogenase deficiency (MCADD) by newborn screening ontario 
BMC Pediatrics  2010;10:82.
Background
Medium chain acyl-CoA dehydrogenase deficiency (MCADD) is a disorder of mitochondrial fatty acid oxidation and is one of the most common inborn errors of metabolism. Identification of MCADD via newborn screening permits the introduction of interventions that can significantly reduce associated morbidity and mortality. This study reports on the first three years of newborn screening for MCADD in Ontario, Canada.
Methods
Newborn Screening Ontario began screening for MCADD in April 2006, by quantification of acylcarnitines (primarily octanoylcarnitine, C8) in dried blood spots using tandem mass spectrometry. Babies with positive screening results were referred to physicians at one of five regional Newborn Screening Treatment Centres, who were responsible for diagnostic evaluation and follow-up care.
Results
From April 2006 through March 2009, approximately 439 000 infants were screened for MCADD in Ontario. Seventy-four infants screened positive, with a median C8 level of 0.68 uM (range 0.33-30.41 uM). Thirty-one of the screen positive infants have been confirmed to have MCADD, while 36 have been confirmed to be unaffected. Screening C8 levels were higher among infants with MCADD (median 8.93 uM) compared to those with false positive results (median 0.47 uM). Molecular testing was available for 29 confirmed cases of MCADD, 15 of whom were homozygous for the common c.985A > G mutation. Infants homozygous for the common mutation tended to have higher C8 levels (median 12.13 uM) relative to compound heterozygotes for c.985A > G and a second detectable mutation (median 2.01 uM). Eight confirmed mutation carriers were identified among infants in the false positive group. The positive predictive value of a screen positive for MCADD was 46%. The estimated birth prevalence of MCADD in Ontario is approximately 1 in 14 000.
Conclusions
The birth prevalence of MCADD and positive predictive value of the screening test were similar to those identified by other newborn screening programs internationally. We observed some evidence of correlation between genotype and biochemical phenotype (C8 levels), and between C8 screening levels and eventual diagnosis. Current research priorities include further examining the relationships among genotype, biochemical phenotype, and clinical phenotype, with the ultimate goal of improving clinical risk prediction in order to provide tailored disease management advice and genetic counselling to families.
doi:10.1186/1471-2431-10-82
PMCID: PMC2996355  PMID: 21083904
23.  A systematic review of the psychometric properties of Quality of Life measures for school aged children with cerebral palsy 
BMC Pediatrics  2010;10:81.
Background
This systematic review aimed to evaluate the psychometric properties and clinical utility of all condition specific outcome measures used to assess quality of life (QOL) in school aged children with cerebral palsy (CP).
Methods
Relevant outcome measures were identified by searching 8 electronic databases, supplemented by citation tracking. Two independent reviewers completed data extraction and analysis of the measures using a modified version of the CanChild Outcome Measures Rating Form.
Results
From the 776 papers identified 5 outcome measures met the inclusion criteria: the Care and Comfort Hypertonicity Questionnaire (C&CHQ), the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), CP QOL-Child, DISABKIDS and PedsQL 3.0 CP Module. There was evidence of construct validity for all five measures. Content validity was reported for all measures except PedsQL 3.0. The CPCHILD and CP QOL-Child were the only outcome measures to have reported data on concurrent validity. All measures, with the exception of one (C&CHQ) provided evidence of internal reliability. The CPCHILD and the CP-QOL-Child had evidence of test-retest reliability and DISABKIDS had evidence of inter-rater reliability. There were no published data on the responsiveness of these outcome measures.
Conclusions
The CPCHILD and the CP QOL-Child demonstrated the strongest psychometric properties and clinical utility. Further work is needed, for all measures, on data for sensitivity to change.
doi:10.1186/1471-2431-10-81
PMCID: PMC2995480  PMID: 21059270
24.  LEARN 2 MOVE 2-3: a randomized controlled trial on the efficacy of child-focused intervention and context-focused intervention in preschool children with cerebral palsy 
BMC Pediatrics  2010;10:80.
Background
Little is known about the efficacy and the working mechanisms of physical and occupational therapy interventions for children with cerebral palsy (CP). In recent years a shift from a child-focused intervention approach to a more context-focused intervention approach can be recognized. Until now the evidence on the efficacy and the working mechanisms of these interventions for children with CP is inconclusive. This study aims to evaluate the efficacy and working mechanisms of two intervention approaches compared to regular care intervention in improving mobility and self-care skills of children (2-3 years) with CP and their families: a child-focused intervention approach and a context-focused intervention approach.
Methods/Design
A multi-centre, randomized controlled trial research design will be used. Ninety-four children with CP (Gross Motor Function Classification System (GMFCS) level I-IV; age 2 to 3 years), their parents, and service providers (physical and occupational therapists) will be included. During a period of six months children will receive child-focused, context-focused or regular care intervention. Therapists will be randomly assigned to deliver either a child-focused intervention approach, a context-focused intervention approach or regular care intervention. Children follow their therapist into the allocated intervention arm. After the six months study-intervention period, all participants return to regular care intervention. Outcomes will be evaluated at baseline, after six months and at a three months follow-up period. Primary outcome is the capability of functional skills in self-care and mobility, using the Functional Skills Scale of the Pediatric Evaluation of Disability Inventory (PEDI). Other outcomes will be quality of life and the domains of the International Classification of Functioning, Disability and Health - for Children and Youth (ICF-CY), including body function and structure, activities (gross motor capacity and performance of daily activities), social participation, environmental variables (family functioning, parental empowerment).
Discussion
This paper presents the background information, design, description of interventions and protocol for this study on the efficacy and working mechanisms of child-focused intervention approach and context-focused intervention approach compared to regular care intervention in mobility and self-care skills of children (2-3 years) with CP.
Trial registration
This study is registered in the Dutch Trial Register as NTR1900
doi:10.1186/1471-2431-10-80
PMCID: PMC2989309  PMID: 21059257
25.  Learn 2 Move 16-24: effectiveness of an intervention to stimulate physical activity and improve physical fitness of adolescents and young adults with spastic cerebral palsy; a randomized controlled trial 
BMC Pediatrics  2010;10:79.
Background
Persons with cerebral palsy (CP) are at risk for developing an inactive lifestyle and often have poor fitness levels, which may lead to secondary health complications and diminished participation and quality of life. However, persons with CP also tend not to receive structural treatment to improve physical activity and fitness in adolescence, which is precisely the period when adult physical activity patterns are established.
Methods
We aim to include 60 adolescents and young adults (16-24 years) with spastic CP. Participants will be randomly assigned to an intervention group or a control group (no treatment; current policy). The intervention will last 6 months and consist of three parts; 1) counselling on daily physical activity; 2) physical fitness training; and 3) sports advice. To evaluate the effectiveness of the intervention, all participants will be measured before, during, directly after, and at 6 months following the intervention period. Primary outcome measures will be: 1) physical activity level, which will be measured objectively with an accelerometry-based activity monitor during 72 h and subjectively with the Physical Activity Scale for Individuals with Physical Disabilities; 2) aerobic fitness, which will be measured with a maximal ramp test on a bicycle or armcrank ergometer and a 6-minute walking or wheelchair test; 3) neuromuscular fitness, which will be measured with handheld dynamometry; and 4 body composition, which will be determined by measuring body mass, height, waist circumference, fat mass and lipid profile.
Conclusions
This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial (LEARN 2 MOVE 16-24) aimed at examining the effectiveness of an intervention that is intended to permanently increase physical activity levels and improve fitness levels of adolescents and young adults with CP by achieving a behavioral change toward a more active lifestyle.
Trial registration
Dutch Trial Register; NTR1785
doi:10.1186/1471-2431-10-79
PMCID: PMC2992500  PMID: 21054829

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