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1.  Significant weight loss in breastfed term infants readmitted for hyperbilirubinemia 
BMC Pediatrics  2009;9:82.
Background
Weight loss of greater than 7% from birth weight indicates possible feeding problems. Inadequate oral intake causes weight loss and increases the bilirubin enterohepatic circulation. The objective of this study was to describe the association between total serum bilirubin (TSB) levels and weight loss in healthy term infants readmitted for hyperbilirubinemia after birth hospitalization.
Methods
We reviewed medical records of breastfed term infants who received phototherapy according to TSB levels readmitted to Caja Petrolera de Salud Clinic in La Paz, Bolivia during January 2005 through October 2008.
Results
Seventy-nine infants were studied (64.6% were males). The hyperbilirubinemia readmission rate was 5% among breastfed infants. Term infants were readmitted at a median age of 4 days. Mean TSB level was 18.6 ± 3 mg/dL. Thirty (38%) had significant weight loss. A weak correlation between TSB levels and percent of weight loss was identified (r = 0.20; p < 0.05). The frequency of severe hyperbilirubinemia (> 20 mg/dL) was notably higher among infants with significant weight loss (46.7% vs. 18.4%; p < 0.05). The risk of having severe hyperbilirubinemia was approximately 4 times greater for infants with significant weight loss (OR: 3.9; 95% CI: 1.4-10.8; p < 0.05).
Conclusions
Significant weight loss could be a useful parameter to identify breastfed term infants at risk of severe hyperbilirubinemia either during birth hospitalization or outpatient follow-up visits in settings where routine pre-discharge TSB levels have not been implemented yet.
doi:10.1186/1471-2431-9-82
PMCID: PMC2806254  PMID: 20043852
2.  Economic and other barriers to adopting recommendations to prevent childhood obesity: results of a focus group study with parents 
BMC Pediatrics  2009;9:81.
Background
Parents are integral to the implementation of obesity prevention and management recommendations for children. Exploration of barriers to and facilitators of parental decisions to adopt obesity prevention recommendations will inform future efforts to reduce childhood obesity.
Methods
We conducted 4 focus groups (2 English, 2 Spanish) among a total of 19 parents of overweight (BMI ≥ 85th percentile) children aged 5-17 years. The main discussion focused on 7 common obesity prevention recommendations: reducing television (TV) watching, removing TV from child's bedroom, increasing physically active games, participating in community or school-based athletics, walking to school, walking more in general, and eating less fast food. Parents were asked to discuss what factors would make each recommendation more difficult (barriers) or easier (facilitators) to follow. Participants were also asked about the relative importance of economic (time and dollar costs/savings) barriers and facilitators if these were not brought into the discussion unprompted.
Results
Parents identified many barriers but few facilitators to adopting obesity prevention recommendations for their children. Members of all groups identified economic barriers (time and dollar costs) among a variety of pertinent barriers, although the discussion of dollar costs often required prompting. Parents cited other barriers including child preference, difficulty with changing habits, lack of information, lack of transportation, difficulty with monitoring child behavior, need for assistance from family members, parity with other family members, and neighborhood walking safety. Facilitators identified included access to physical activity programs, availability of alternatives to fast food and TV which are acceptable to the child, enlisting outside support, dietary information, involving the child, setting limits, making behavior changes gradually, and parental change in shopping behaviors and own eating behaviors.
Conclusions
Parents identify numerous barriers to adopting obesity prevention recommendations, most notably child and family preferences and resistance to change, but also economic barriers. Intervention programs should consider the context of family priorities and how to overcome barriers and make use of relevant facilitators during program development.
doi:10.1186/1471-2431-9-81
PMCID: PMC2806253  PMID: 20025769
3.  Effect of provider-initiated testing and counselling and integration of ART services on access to HIV diagnosis and treatment for children in Lilongwe, Malawi: a pre- post comparison 
BMC Pediatrics  2009;9:80.
Background
The HIV prevalence in Malawi is 12% and Kamuzu Central Hospital (KCH), in the capital Lilongwe, is the main provider of adult and paediatric HIV services in the central region. The Lighthouse at KCH offers opt-in HIV testing and counselling (HTC) for adults and children. In June 2004, Lighthouse was the first clinic to provide free antiretroviral treatment (ART) in the public sector, but few children accessed the services. In response, provider-initiated HIV testing and counselling (PITC) and an ART clinic were introduced at the paediatric department at KCH in Quarter 4 (Q4) 2004.
Methods
We analysed prospectively collected, aggregated data of quarterly reports from Q1 2003 to Q4 2006 from HTC centre registers, ART registers and clinic registrations at the ART clinics of both Lighthouse and the paediatric department. By comparing data of both facilities before (Q1 2003 to Q3 2004), and after the introduction of the services at the paediatric department (Q4 2004 to Q4 2006), we assessed the effect of this intervention on the uptake of HIV services for children at KCH.
Results
Overall, 3971 children were tested for HIV, 2428 HIV-infected children were registered for care and 1218 started ART. Between the two periods, the median (IQR) number of children being tested, registered and starting ART per quarter rose from 101 (53-109) to 358 (318-440), 56 (50-82) to 226 (192-234) and 18 (8-23) to 139 (115-150), respectively. The median proportion of tested clients per quarter that were children rose from 3.8% (2.7-4.3) to 9.6% (8.8 to 10.0) (p = 0.0009) and the proportion of ART starters that were children rose from 6.9% (4.9-9.3) to 21.1% (19.2-24.2) (p = 0.0036). The proportion of registered children and adults starting ART each quarter increased similarly, from 26% to 53%, and 20% to 52%, respectively.
Conclusions
Implementation of PITC and integration of ART services within the paediatric ward are likely to be the main reasons for improved access to HTC and ART for children at KCH, and can be recommended to other hospitals with paediatric inpatients in resource limited settings with high HIV prevalence.
doi:10.1186/1471-2431-9-80
PMCID: PMC2803160  PMID: 20021641
4.  Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) 
BMC Pediatrics  2009;9:79.
Background
The prognosis for young people diagnosed with diabetes during childhood remains poor and this is mainly related to the long-term risk of developing vascular complications.
Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN) and cardiovascular disease (CVD). It is often detected in adolescence but is rarely treated before the age of 18 years, as at the end of puberty albumin excretion may decline and in some subjects will return into the normal range. However, evidence indicates that subjects with both transient and persistent microalbuminuria have experienced renal damage during puberty and thus reno-protection to prevent long-term complications is warranted. In adults with diabetes and microalbuminuria, the use of angiotensin converting enzyme inhibitors (ACEI) and Statins is increasing, and in order to determine whether these agents are of value in the adolescent population a large randomized controlled clinical trial is needed.
Methods/Design
The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) is a multi-center, randomized, double-blind, placebo-controlled trial of ACEI and Statin therapy in adolescents with type 1 diabetes. 500 high-risk adolescents, defined on the basis of their albumin excretion, are randomized to receive either ACEI (Quinapril) or Statins (Atorvastatin) or combination therapy or placebo for 3-4 years. There will also be a parallel open observational study, based on the follow-up of 400 low-risk non-randomized adolescents. The major endpoint of the study is the change in albumin excretion; secondary endpoints include markers of CVD, renal function, retinopathy, quality of life combined with assessment of compliance and potential health economic benefits.
Discussion
AdDIT will provide important data on the potential renal and cardiovascular protective effects of ACEI and Statins in high-risk adolescents. Long-term follow-up of the randomized subjects will provide direct evidence of disease outcomes, in addition to the data on early surrogate measures of DN and CVD. Follow-up of non-randomized low-risk subjects will determine the potential impact of intervention on DN and CVD. AdDIT will help to determine whether, in addition to encouraging young people to achieve good glycaemic control, pharmacological cardio-renal protection should also be implemented.
EudraCT Number
2007-001039-72
Trial Registration Number
ISRCTN91419926
doi:10.1186/1471-2431-9-79
PMCID: PMC2814806  PMID: 20017932
5.  Motor ability in children treated for idiopathic clubfoot. A controlled pilot study 
BMC Pediatrics  2009;9:78.
Background
To study motor ability at seven years of age in children treated for idiopathic clubfoot and its relation to clubfoot laterality, foot status and the amount of surgery performed.
Methods
Twenty children (mean age 7.5 years, SD 3.2 months) from a consecutive birth cohort from our hospital catchments area (300.000 inhabitants from southern Sweden) were assessed with the Movement Assessment Battery for Children (MABC) and the Clubfoot Assessment Protocol (CAP).
Results
Compared to typically developing children an increased prevalence of motor impairment was found regarding both the total score for MABC (p < 0.05) and the subtest ABC-Ball skills (p < 0.05). No relationship was found between the child's actual foot status, laterality or the extent of foot surgery with the motor ability as measured with MABC. Only the CAP item "one-leg stand" correlated significantly with the MABC (rs = -0.53, p = 0.02).
Conclusions
Children with idiopathic clubfoot appear to have an increased risk of motor activity limitations and it is possible that other factors, independent of the clinical status, might be involved. The ability to keep balance on one leg may be a sufficient tool for determining which children in the orthopedic setting should be more thoroughly evaluated regarding their neuromotor functioning.
doi:10.1186/1471-2431-9-78
PMCID: PMC2804569  PMID: 20003483
6.  A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials 
BMC Pediatrics  2009;9:77.
Background
Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.
Methods
We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.
Results
110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.
Conclusions
Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.
doi:10.1186/1471-2431-9-77
PMCID: PMC2801486  PMID: 20003383
7.  Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial) 
BMC Pediatrics  2009;9:76.
Background
Co-bedding, a developmental care strategy, is the practice of caring for diaper clad twins in one incubator (versus separating and caring for each infant in separate incubators), thus creating the opportunity for skin-to-skin contact and touch between the twins. In studies of mothers and their infants, maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. The intent of this study is to compare the comfort effect of co-bedding (between twin infants who are co-bedding and those who are not) on infant pain response and physiologic stability during a tissue breaking procedure (heelstick).
Methods/Design
Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be randomly assigned to a co-bedding group or a standard care group. Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale (PIPP). Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline. Sixty four sets of twins (n = 128) will be recruited into the study. Analysis and inference will be based on the intention-to-treat principle.
Discussion
If twin contact while co-bedding is determined to have a comforting effect for painful procedures, then changes in current neonatal care practices to include co-bedding may be an inexpensive, non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population. Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch.
Trial registration
NCT00917631
doi:10.1186/1471-2431-9-76
PMCID: PMC2804568  PMID: 20003351
8.  A survey on knowledge and self-reported formula handling practices of parents and child care workers in Palermo, Italy 
BMC Pediatrics  2009;9:75.
Background
Powdered infant formula (PIF) is not a sterile product, but this information appears to be poorly diffused among child caregivers. Parents and child care workers may behave in an unsafe manner when handling PIF.
Methods
This study involved parents and child care workers in the 24 municipal child care centres of Palermo. Knowledge and self-reported practices about PIF handling were investigated by a structured questionnaire. A Likert scale was used to measure the strength of the respondent's feelings. Association of knowledge and self-reported practices with demographic variables was also evaluated.
Results
42.4% of parents and 71.0% of child care workers filled in the questionnaire. Significant differences were found between parents and child care workers for age and education. 73.2% of parents and 84.4% of child care workers were confident in sterility of PIF. Generally, adherence to safe procedures when reconstituting and handling PIF was more frequently reported by child care workers who, according to the existing legislation, are regularly subjected to a periodic training on food safety principles and practices. Age and education significantly influenced the answers to the questionnaire of both parents and child care workers.
Conclusion
The results of the study reveal that parents and child care workers are generally unaware that powdered formulas may contain viable microorganisms. However, child care workers consistently chose safer options than parents when answering the questions about adherence to hygienic practices.
At present it seems unfeasible to produce sterile PIF, but the risk of growth of hazardous organisms in formula at the time of administration should be minimized by promoting safer behaviours among caregivers to infants in both institutional settings and home.
doi:10.1186/1471-2431-9-75
PMCID: PMC2796653  PMID: 20003304
9.  Development and tracking of central patterns of subcutaneous fat of rural South African youth: Ellisras longitudinal study 
BMC Pediatrics  2009;9:74.
Background
Individuals grow and accumulate central patterns of body fat into the diseases they will suffer from as older adults. The need to elicit the development and tracking of central patterns of body fat from younger age into adolescent remains to be explored.
Method
Skinfolds measurements were done according to the standard procedures in the Ellisras Longitudinal Growth and Health Study. In total, 2,225 children--550 preschool and 1,675 primary school--aged 3-10 years (birth cohorts 1993 to 1986) were enrolled at baseline in 1996 and followed through out the eight-year periodic surveys. In 2003, 1,771 children--489 preschool and 1,282 primary school--were still in the study.
Results
The development of triceps, biceps, suprailiac and suscapular skinfolds of Ellisras girls were significantly higher (p < 0.001 to 0.05) compared to boys over time. The tracking coefficient between the initial measurements and the subsequent measurements was higher for skinfolds (r about 0.63) than for skinfold ratios (r about 0.43). Longitudinal tracking coefficient measuring the association between the initial measurements and all the follow up measurements simultaneously was about 0.57.
Conclusion
The accumulation of central patterns of body fat of Ellisras children starts in childhood and adolescence spurt with Ellisras girls acquiring more than boys over time. High significant tracking of skinfold thickness while the skinfold ratios show low and insignificant tracking over time. The magnitude of central patterns of body fat accumulation over time requires further investigation to clarify their association with risk factors for cardiovascular diseases.
doi:10.1186/1471-2431-9-74
PMCID: PMC2797006  PMID: 20003226
10.  Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home 
BMC Pediatrics  2009;9:73.
Background
Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems.
Methods/Design
We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires.
Discussion
This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age.
Clinical Trial Registration Number
ACTRN12605000492651
doi:10.1186/1471-2431-9-73
PMCID: PMC2797495  PMID: 19954550
11.  Clinical parameters predicting failure of empirical antibacterial therapy in early onset neonatal sepsis, identified by classification and regression tree analysis 
BMC Pediatrics  2009;9:72.
Background
About 10-20% of neonates with suspected or proven early onset sepsis (EOS) fail on the empiric antibiotic regimen of ampicillin or penicillin and gentamicin. We aimed to identify clinical and laboratory markers associated with empiric antibiotic treatment failure in neonates with suspected EOS.
Methods
Maternal and early neonatal characteristics predicting failure of empiric antibiotic treatment were identified by univariate logistic regression analysis from a prospective database of 283 neonates admitted to neonatal intensive care unit within 72 hours of life and requiring antibiotic therapy with penicillin or ampicillin and gentamicin. Variables, identified as significant by univariate analysis, were entered into stepwise multiple logistic regression (MLR) analysis and classification and regression tree (CRT) analysis to develop a decision algorithm for clinical application. In order to ensure the earliest possible timing separate analysis for 24 and 72 hours of age was performed.
Results
At 24 hours of age neonates with hypoglycaemia ≤ 2.55 mmol/L together with CRP values > 1.35 mg/L or those with BW ≤ 678 g had more than 30% likelihood of treatment failure. In normoglycaemic neonates with higher BW the best predictors of treatment failure at 24 hours were GA ≤ 27 weeks and among those, with higher GA, WBC ≤ 8.25 × 109 L-1 together with platelet count ≤ 143 × 109 L-1. The algorithm allowed capture of 75% of treatment failure cases with a specificity of 89%. By 72 hours of age minimum platelet count ≤ 94.5 × 109 L-1 with need for vasoactive treatment or leukopaenia ≤ 3.5 × 109 L-1 or leukocytosis > 39.8 × 109 L-1 or blood glucose ≤ 1.65 mmol/L allowed capture of 81% of treatment failure cases with the specificity of 88%. The performance of MLR and CRT models was similar, except for higher specificity of the CRT at 72 h, compared to MLR analysis.
Conclusion
There is an identifiable group of neonates with high risk of EOS, likely to fail on conventional antibiotic therapy.
doi:10.1186/1471-2431-9-72
PMCID: PMC2789707  PMID: 19930706
12.  Late preterm birth is a risk factor for growth faltering in early childhood: a cohort study 
BMC Pediatrics  2009;9:71.
Background
Rates of preterm birth are increasing worldwide and this increase is mostly due to infants born between 34 and 36 weeks of gestational age, the so-called "late preterm" births. The aim of this study was to assess the effect of late preterm birth over growth outcomes, assessed when children were 12 and 24 months old.
Methods
In 2004, all births taking place in Pelotas (Southern Brazil) were recruited for a cohort study. Late preterm (34/0-36/6 weeks of gestational age) and term children (37/0-42/6 weeks) were compared in terms of weight-for-age, length-for-age and weight-for-length z-scores. Weight-for-age, length-for-age and weight-for-length z-scores below -2 were considered, respectively, underweight, stunting and wasting. Singleton newborns with adequate weight for gestational age at birth, successfully followed-up either at 12 or 24 months of age were analyzed and adjusted odds ratios with 95% confidence intervals calculated through logistic regression.
Results
3285 births were included, 371 of whom were late preterm births (11.3%). At 12 months, prevalence of underweight, stunting and wasting were, respectively, 3.4, 8.7 and 1.1% among late preterm children, against 1.0, 3.4 and 0.3% among term children. At 24 months, correspondent values were 3.0, 7.2 and 0.8% against 0.8, 2.9 and 0.4%. Comparing with the term children, adjusted odds of being underweighted among late preterm children was 2.57 times higher (1.27; 5.23) at 12 months and 3.36 times higher (1.56; 7.23) at 24; of being stunted, 2.35 (1.49; 3.70) and 2.30 (1.40; 3.77); and of being wasted, 3.98 (1.07; 14.85) and 1.87 (0.50; 7.01). Weight gain from birth to 12 and 24 months was similar in late preterm and term children, whereas length gain was higher in the former group in both periods.
Conclusion
Late preterm children grow faster than children born at term, but they are at increased risk of underweight and stunting in the first two years of life. Failure to thrive in the first two years may put them at increased risk of future occurrences of serious morbidity in late childhood and of chronic disease development in adult life.
doi:10.1186/1471-2431-9-71
PMCID: PMC2780991  PMID: 19917121
13.  Comparison of a new transcutaneous bilirubinometer (Bilimed®) with serum bilirubin measurements in preterm and full-term infants 
BMC Pediatrics  2009;9:70.
Background
The gold standard to assess hyperbilirubinemia in neonates remains the serum bilirubin measurement. Unfortunately, this is invasive, painful, and costly. Bilimed®, a new transcutaneous bilirubinometer, suggests more accuracy compared to the existing non-invasive bilirubinometers because of its new technology. It furthermore takes into account different skin colours. No contact with the skin is needed during measurement, no additional material costs occur. Our aim was to assess the agreement between the Bilimed® and serum bilirubin in preterm and term infants of different skin colours.
Methods
The transcutaneous bilirubin measurements were performed on the infant's sternum and serum bilirubin was determined simultaneously. The agreement between both methods was assessed by Pearson's correlation and by Bland-Altman analysis.
Results
A total of 117 measurement cycles were performed in 99 term infants (group1), further 47 measurements in 38 preterm infants born between 34 - 36 6/7 gestational weeks (group 2), and finally 21 measurements in 13 preterm infants born between 28 - 33 6/7 gestational weeks (group 3). The mean deviation and variability (+/- 2SD) of the transcutaneous from serum bilirubin were: -14 (+/- 144) μmol/l; -0.82 (+/- 8.4) mg/dl in group 1, +16 (+/- 91) μmol/l;+0.93(+/- 5.3) mg/dl in group 2 and -8 (+/- 76) μmol/l; -0.47 (+/- 4.4) mg/dl in group 3. These limits of agreement are too wide to be acceptable in a clinical setting. Moreover, there was to be a trend towards less good agreement with increasing bilirubin values.
Conclusion
Despite its new technology the Bilimed® has no advantages, and more specifically no better agreement not only in term and near-term Caucasian infants, but also in non-Caucasian and more premature infants.
doi:10.1186/1471-2431-9-70
PMCID: PMC2784449  PMID: 19909530
14.  Why do paediatricians prescribe antibiotics? Results of an Italian regional project 
BMC Pediatrics  2009;9:69.
Background
To investigate determinants of antibiotic prescription in paediatric care, as a first step of a multilevel intervention to improve prescribing for common respiratory tract infections (RTIs) in a northern Italian region with high antibiotic prescription rate.
Methods
A two-step survey was performed: in phase I, knowledge, and attitudes were explored involving all family and hospital paediatricians of Emilia-Romagna and a sample of parents. In phase II, patient care practices were explored in a stratified random sample of visits, both in hospitals and family physician's clinics; parent expectations were investigated in a sub-sample of these visits.
Results
Out of overall 4352 visits for suspected RTIs, in 38% of children an antibiotic was prescribed. Diagnostic uncertainty was perceived by paediatricians as the most frequent cause of inappropriate prescription (56% of 633 interviewed paediatricians); but, rapid antigen detecting tests was used in case of pharyngitis/pharyngotonsillitis by 36% and 21% of family and hospital paediatricians only. More than 50% of paediatricians affirmed to not adopt a "wait and see strategy" in acute otitis. The perceived parental expectation of antibiotics was not indicated by paediatricians as a crucial determinant of prescription, but this perception was the second factor most strongly associated to prescription (OR = 12.8; 95% CI 10.4 - 15.8), the first being the presence of othorrea. Regarding parents, the most important identified factors, potentially associated to overprescribing, were the lack of knowledge of RTIs and antibiotics (41% of 1029 parents indicated bacteria as a possible cause of common cold), and the propensity to seek medical care for trivial infections (48% of 4352 children accessing ambulatory practice presented only symptoms of common cold).
Conclusion
A wide gap between perceived and real determinants of antibiotic prescription exists. This can promote antibiotic overuse. Inadequate parental knowledge can also induce inappropriate prescription. The value of this study is that it simultaneously explored determinants of antimicrobial prescribing in an entire region involving both professionals and parents.
doi:10.1186/1471-2431-9-69
PMCID: PMC2777860  PMID: 19895678
15.  Health related quality of life of Dutch children: psychometric properties of the PedsQL in the Netherlands 
BMC Pediatrics  2009;9:68.
Background
Knowledge about psychometric properties of the Pediatric Quality of Life Inventory (PedsQL) in the Netherlands is limited and Dutch reference data are lacking. Aim of the current study is to collect Dutch reference data of the PedsQL and subsequently assess reliability, socio-demographic within-group differences and construct validity.
Methods
In this study the PedsQL was administered to Dutch children aged 5 to 18 years. A socio-demographic questionnaire was completed as well. The sample consisted of three age groups: 5-7 years (parent proxy report), 8-12 years and 13-18 years (child self report). Analysis was performed with SPSS 16.0.2. A reliability analysis was done using Cronbach's alpha coefficient. Socio-demographic within-group differences were assessed by means of an ANOVA with post hoc Bonferroni correction and t-tests. Subsequently, construct validity was determined by t-tests and effect sizes.
Results
For 496 children PedsQL reference data were collected. PedsQL total scores were 84.18 (group 5-7), 82.11 (group 8-12) and 82.24 (group 13-18). Internal consistency coefficients ranged from .53 to .85. Socio-demographic within-group differences demonstrated that, in group 8-12, children of parents born in the Netherlands had significantly lower scores on several PedsQL subscales, compared to children of parents born in another country. With respect to construct validity, healthy children of group 5-7 and 13-18 scored significantly higher than children with a chronic health condition on all subscales, except for emotional functioning. In group 5-7, the PedsQL total score for healthy children was 85.31, whereas the same age group with a chronic health condition scored 78.80. Effect sizes in this group varied from 0.58 to 0.88. With respect to group 13-18, healthy children obtained a PedsQL total score of 83.14 and children suffering from a chronic health condition 77.09. Effect sizes in this group varied from 0.45 to 0.67. No significant differences were found in group 8-12 regarding health.
Conclusion
The Dutch version of the PedsQL has adequate psychometric properties and can be used as a health related quality of life instrument in paediatric research in the Netherlands.
doi:10.1186/1471-2431-9-68
PMCID: PMC2776579  PMID: 19887000
16.  Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial 
BMC Pediatrics  2009;9:67.
Background
The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data.
Methods
The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth.
Discussion
Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia.
Trial Registration
ClinicalTrials.gov (NCT00434408)
doi:10.1186/1471-2431-9-67
PMCID: PMC2770449  PMID: 19845951
17.  The relationship of bottle feeding and other sucking behaviors with speech disorder in Patagonian preschoolers 
BMC Pediatrics  2009;9:66.
Background
Previous studies have shown that children's nonnutritive sucking habits may lead to delayed development of their oral anatomy and functioning. However, these findings were inconsistent. We investigated associations between use of bottles, pacifiers, and other sucking behaviors with speech disorders in children attending three preschools in Punta Arenas (Patagonia), Chile.
Methods
Information on infant feeding and sucking behaviors, age starting and stopping breast- and bottle-feeding, pacifier use, and other sucking behaviors, was collected from self-administered questionnaires completed by parents. Evaluation of speech problems was conducted at preschools with subsequent scoring by a licensed speech pathologist using age-normative standards.
Results
A total of 128 three- to five-year olds were assessed, 46% girls and 54% boys. Children were breastfed for an average of 25.2 (SD 9.6) months and used a bottle 24.4 (SD 15.2) months. Fifty-three children (41.7%) had or currently used a pacifier for an average of 11.4 (SD 17.3) months; 23 children (18.3%) were reported to have sucked their fingers. Delayed use of a bottle until after 9 months appeared to be protective for subsequent speech disorders. There was less than a one-third lower relative odds of subsequent speech disorders for children with a delayed use of a bottle compared to children without a delayed use of a bottle (OR: 0.32, 95% CI: 0.10-0.98). A three-fold increase in relative odds of speech disorder was found for finger-sucking behavior (OR: 2.99, 95% CI: 1.10-8.00) and for use of a pacifier for 3 or more years (OR: 3.42, 95% CI: 1.08-10.81).
Conclusion
The results suggest extended use of sucking outside of breastfeeding may have detrimental effects on speech development in young children.
doi:10.1186/1471-2431-9-66
PMCID: PMC2773774  PMID: 19845936
18.  Evaluation of seasonal patterns of Kawasaki Syndrome- and rotavirus-associated hospitalizations in California and New York, 2000-2005 
BMC Pediatrics  2009;9:65.
Background
Kawasaki Syndrome (KS) is an uncommon childhood disease with unknown etiology. It has been suggested that rotavirus infection may play a causative role in the development of KS.
Methods
To examine potential temporal associations between KS and rotavirus infection, seasonal patterns of KS- and rotavirus-associated hospitalizations among children in California and New York during 2000-2005 were compared.
Results
Rotavirus hospital admissions were markedly winter seasonal, with very few summer hospitalizations. KS hospitalizations occurred year-round but also peaked slightly during winter and spring.
Conclusion
The strong winter seasonal pattern of rotavirus clearly differed from the year-round pattern of KS hospitalizations. While the present study cannot completely rule out rotavirus as having a role in the development of KS, other agents must be involved in the etiology of KS.
doi:10.1186/1471-2431-9-65
PMCID: PMC2768681  PMID: 19835612
19.  Prevalence and risk factors for stunting and severe stunting among under-fives in North Maluku province of Indonesia 
BMC Pediatrics  2009;9:64.
Background
Adequate nutrition is needed to ensure optimum growth and development of infants and young children. Understanding of the risk factors for stunting and severe stunting among children aged less than five years in North Maluku province is important to guide Indonesian government public health planners to develop nutrition programs and interventions in a post conflict area. The purpose of the current study was to assess the prevalence of and the risk factors associated with stunting and severe stunting among children aged less than five years in North Maluku province of Indonesia.
Methods
The health and nutritional status of children aged less than five years was assessed in North Maluku province of Indonesia in 2004 using a cross-sectional multi-stage survey conducted on 750 households from each of the four island groups in North Maluku province. A total of 2168 children aged 0-59 months were used in the analysis.
Results
Prevalence of stunting and severe stunting were 29% (95%CI: 26.0-32.2) and 14.1% (95%CI: 11.7-17.0) for children aged 0-23 months and 38.4% (95%CI: 35.9-41.0) and 18.4% (95%CI: 16.1-20.9) for children aged 0-59 months, respectively. After controlling for potential confounders, multivariate analysis revealed that the risk factors for stunted children were child's age in months, male sex and number of family meals per day (≤2 times), for children aged 0-23 months, and income (poorest and middle-class family), child's age in months and male sex for children aged 0-59 months. The risk factors for severe stunting in children aged 0-23 months were income (poorest family), male sex and child's age in months and for children aged 0-59 months were income (poorest family), father's occupation (not working), male sex and child's age in months.
Conclusion
Programmes aimed at improving stunting in North Maluku province of Indonesia should focus on children under two years of age, of male sex and from families of low socioeconomic status.
doi:10.1186/1471-2431-9-64
PMCID: PMC2765943  PMID: 19818167
20.  ADEPT - Abnormal Doppler Enteral Prescription Trial 
BMC Pediatrics  2009;9:63.
Background
Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice.
Methods and Design
Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age) using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months.
Discussion
There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also provide pointers for future research.
Trial registration
Current Controlled Trials ISRCTN: 87351483
doi:10.1186/1471-2431-9-63
PMCID: PMC2770036  PMID: 19799788
21.  Experiences of training and implementation of integrated management of childhood illness (IMCI) in South Africa: a qualitative evaluation of the IMCI case management training course 
BMC Pediatrics  2009;9:62.
Background
Integrated Management of Childhood Illness (IMCI) is a strategy to reduce mortality and morbidity in children under-5 years by improving management of common illnesses at primary level. IMCI has been shown to improve health worker performance, but constraints have been identified in achieving sufficient coverage to improve child survival, and implementation remains sub-optimal. At the core of the IMCI strategy is a clinical guideline whereby health workers use a series of algorithms to assess and manage a sick child, and give counselling to carers. IMCI is taught using a structured 11-day training course that combines classroom work with clinical practise; a variety of training techniques are used, supported by comprehensive training materials and detailed instructions for facilitators.
Methods
We conducted focus group discussions with IMCI trained health workers to explore their experiences of the methodology and content of the IMCI training course, whether they thought they gained the skills required for implementation, and their experiences of follow-up visits.
Results
Health workers found the training interesting, informative and empowering, and there was consensus that it improved their skills in managing sick children. They appreciated the variety of learning methods employed, and felt that repetition was important to reinforce knowledge and skills. Facilitators were rated highly for their knowledge and commitment, as well as their ability to identify problems and help participants as required. However, health workers felt strongly that the training time was too short to acquire skills in all areas of IMCI. Their increased confidence in managing sick children was identified by health workers as an enabling factor for IMCI implementation in the workplace, but additional time required for IMCI consultations was expressed as a major barrier. Although follow-up visits were described as very helpful, these were often delayed and there was no ongoing clinical supervision.
Conclusion
The IMCI training course was reported to be an effective method of acquiring skills, but more time is required, either during the course, or with follow-up, to improve IMCI implementation. Innovative solutions may be required to ensure that adequate skills are acquired and maintained.
doi:10.1186/1471-2431-9-62
PMCID: PMC2765431  PMID: 19796377
22.  Bone and body composition analyzed by Dual-energy X-ray Absorptiometry (DXA) in clinical and nutritional evaluation of young patients with Cystic Fibrosis: a cross-sectional study 
BMC Pediatrics  2009;9:61.
Background
the improved general therapy has led to reduced morbidity and mortality from Cystic Fibrosis (CF), and bone status may have a potentially greater clinical impact.
We investigated the correlation between the severity of the clinical condition, bone status and body composition parameters, in a group of children and young adults with CF.
Methods
we measured lumbar spine bone density and total body composition by dual energy x-ray absorptiometry (DXA) in 82 consecutive CF patients (42 males; median age: 13 years - range: 5-30). Eighty-two healthy subjects, matched for age, gender, height and pubertal stage were recruited as a control group.
Results
37 patients (45.1%) had a normal bone mineral density (BMD). A BMD reduction were observed in 45 (54.8%) patients. Lumbar spine Z score was positively related to Body Mass Index (BMI) and a higher Shwachman-Kulczycki score, and negatively related to Crispin-Norman score. A positive and significant correlation was also observed between lumbar spine Z score and total body composition.
Conclusion
a significant BMD reduction can be present early in CF children and adolescents. A careful follow up of bone status is required starting in childhood.
doi:10.1186/1471-2431-9-61
PMCID: PMC2760551  PMID: 19785733
23.  Predictors of the early introduction of solid foods in infants: results of a cohort study 
BMC Pediatrics  2009;9:60.
Background
The early introduction of solid foods before 4 months of age has been associated with an increased risk of diarrhoea in infancy and a greater risk of wheeze and increased percentage body fat and weight in childhood. The purpose of this study was to identify the level of compliance with national recommendations related to the timing of the introduction of solid foods and to describe the maternal and infant characteristics associated with the timing of the introduction of solids.
Methods
Subjects were 519 participants in the second longitudinal Perth Infant Feeding Study (PIFS II) recruited from two maternity hospitals in Perth, Western Australia in 2002/3. Data collected prior to, or shortly after discharge from hospital, and at 4, 10, 16, 22, 32, 40 and 52 weeks postpartum included timing of the introduction of solid foods and a variety of maternal and infant characteristics associated with the introduction of solid foods. Multivariate logistic regression was used to identify those factors associated with the risk of introducing solid foods early, which for the purposes of this study was defined as being before 17 weeks.
Results
The median age of introduction of solid foods was 17.6 weeks. In total, 44% of infants had received solids before 17 weeks and 93% of infants had received their first solids before 26 weeks of age. The strongest independent predictors of the early introduction of solids were young maternal age, mother smoking prior to pregnancy and not fully breastfeeding at 4 weeks postpartum. In general, mothers introduced solids earlier than recommended because they perceived their baby to either need them or be ready for them.
Conclusion
This study showed a high level of non-compliance among Australian mothers with the infant feeding recommendation related to the timing of solids that was current at the time. In order to improve compliance health professionals need to be aware of those groups least likely to comply with recommendations and their reasons for non-compliance. Infant feeding recommendations need to be evidence-based, uniformly supported by professionals and widely, clearly and consistently articulated if higher rates of compliance are to be achieved in the future.
doi:10.1186/1471-2431-9-60
PMCID: PMC2754451  PMID: 19772610
24.  Paediatric HIV management at primary care level: an evaluation of the integrated management of childhood illness (IMCI) guidelines for HIV 
BMC Pediatrics  2009;9:59.
Background
Integrated Management of Childhood Illness (IMCI) is a WHO/UNICEF strategy to improve child survival in resource poor settings. South Africa adopted IMCI in 1997, and IMCI guidelines were adapted to include identification and management of HIV infected and exposed children. This study describes the validity of the IMCI/HIV algorithm when used by IMCI experts, the use of IMCI/HIV guidelines by IMCI trained health workers in routine clinical practice, and the burden of HIV among children under 5 years attending first level health facilities.
Methods
Seventy seven randomly selected IMCI trained health workers were observed in 74 health facilities in two provinces of South Africa. Consultations were observed with 1357 sick children; each child was reassessed by an IMCI expert to confirm the correct findings. Consent was requested for HIV testing of all children who attended with a parent or legal guardian. Positive rapid HIV tests were confirmed with HIV PCR in children aged less than 18 months. HIV positive children had a CD4 count and HIV clinical staging done.
Results
Of 1064 children with HIV results available, 76 (7.1% CI: 5.7% - 8.9%) children were confirmed HIV positive. IMCI experts using the HIV algorithm classified 54/76 (71.1% CI: 59.5%-80.9%) HIV positive children as suspected symptomatic HIV, and 15/22 remaining HIV positive children were identified as HIV exposed. Therefore, 69/76 (90.8% CI: 81.9-96.2) HIV infected children were identified by IMCI experts. No classification was made for HIV by observed health workers in 899/1357(66.2%) children.
906/1243(72.9%) mothers had been tested previously for HIV, of whom 221(24.4%) reported testing positive. Of 221 children therefore identified as HIV exposed, only 78(35.3%) had been tested for HIV within routine services.
Conclusion
The HIV algorithm is a valid tool for identifying HIV infected and exposed children when correctly and comprehensively implemented. However, it is not being used by IMCI trained health workers in routine practise, leading to a failure to implement life saving interventions.
doi:10.1186/1471-2431-9-59
PMCID: PMC2754450  PMID: 19772599
25.  Rationales, design and recruitment for the Elfe longitudinal study 
BMC Pediatrics  2009;9:58.
Background
Many factors act simultaneously in childhood to influence health status, life chances and well being, including pre-birth influences, the environmental pollutants of early life, health status but also the social influences of family and school. A cohort study is needed to disentangle these influences and explore attribution.
Methods
Elfe will be a nationally representative cohort of 20 000 children followed from birth to adulthood using a multidisciplinary approach. The cohort will be based on the INSEE Permanent Demographic Panel (EDP) established using census data and civil records. The sample size has been defined in order to match the representativeness criteria and to obtain some prevalence estimation, but also to address the research area of low exposure/rare effects. The cohort will be based on repeated surveys by face to face or phone interview (at birth and each year) as well as medical interview (at 2 years) and examination (at 6 years). Furthermore, biological samples will be taken at birth to evaluate the foetal exposition to toxic substances, environmental sensors will be placed in the child's homes. Pilot studies have been initiated in 2007 (500 children) with an overall acceptance rate of 55% and are currently under progress, the 2-year survey being carried out in October this year.
Discussion
The longitudinal study will provide a unique source of data to analyse the development of children in their environment, to study the various factors interacting throughout the life course up to adulthood and to determine the impact of childhood experience on the individual's physical, psychological, social and professional development.
doi:10.1186/1471-2431-9-58
PMCID: PMC2754449  PMID: 19772571

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