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1.  Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial 
Trials  2015;16:46.
Acute gastroenteritis is a major cause of pediatric morbidity and mortality, accounting for 15% of all childhood deaths worldwide. In developing countries, diarrheal diseases continue to be a major public health burden. Evidence from developed countries suggests that intake of lactose-free milk during diarrheal episodes may reduce the duration of the illness in pediatric inpatients. It is unknown whether lactose-free milk reduces the severity or duration of acute gastroenteritis in infants treated in outpatient settings in developing countries where diarrhea is more severe, and results in higher morbidities and mortalities. We hypothesize that lactose-free milk intake during acute gastroenteritis would significantly decrease the duration and severity of diarrhea in infants presenting to the Emergency Department (ED), as compared with lactose-containing milk.
An open-label randomized clinical trial. Study population: 40 infants with acute gastroenteritis, age between 2 and 12 months, presenting to the ED, will be randomized to control or intervention group. Intervention: Lactose-free milk, whereas the control group will continue on regular infant formula for a total of 7 days. Infants will be followed up for 7 days. Outcome measures: Diarrhea duration, weight loss, illness clinic visits, hospitalization rate, parental satisfaction, and time to symptom resolution. Statistical analysis: Descriptive and regression analysis will be conducted under the intention-to-treat basis by using SPSS version 21.
Acute gastroenteritis is a public health burden for developing countries, with a significant impact on infant morbidity and mortality. Provision of infant formula that may reduce the duration and severity of diarrhea can decrease this burden in countries with limited healthcare resources, like Lebanon. The findings from this study are anticipated to provide evidence-based dietary recommendations for ambulatory infants with acute diarrhea in developing countries.
Trial registration NCT02246010; September 2014.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0565-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4324790
Acute gastroenteritis; Lactose-free milk; Developing world
2.  Axillary and rectal thermometry in the newborn: do they agree? 
BMC Research Notes  2014;7(1):584.
Accurate measurement of body temperature is critical for the assessment of a newborn’s general well-being. In nursery settings, the gold standard rectal thermometry has been replaced by the axillary method. However, evidence pertaining to the agreement between axillary and rectal thermometry in the newborn is controversial. In this cross-sectional study, the agreement between axillary and rectal temperature in newborns, as well as the effects of neonatal, maternal and environmental factors on this agreement were investigated.
The mean difference between axillary and rectal temperatures was compared in stable term and preterm newborns using paired t-test for the means of differences, Pearson correlation coefficient (r), and the Bland-Altman plot. Stepwise multivariate regression assessed predictors of this difference in the overall group and by gestational age categories.
The study included 118 newborns with gestational ages ranging from 29 to 41 weeks, median birth weight of 2980 grams (IQR: 2321.3-3363.8). Axillary and rectal temperatures correlated significantly (r = 0.5, p = 0.000) and had similar overall means but differed in 34–36 weeks gestation newborns (p = 0.01). Correlation between both methods increased with advancing gestational age being highest in term newborns (r = 0.6, p = 0.000). Bland-Altman plots revealed good agreement in gestational ages above 29 weeks. The difference between measurements increased with Cesarean delivery (ß = 0.2; 95% CI: 0.02, 0.38), but decreased with advancing chronological age (ß = -0.01; 95% CI: -0.02,-0.01), and with gestational age (ß = -0.05; 95% CI: -0.08,-0.01).
In clinically stable term and preterm infants, axillary thermometry is as reliable as rectal measurement. Predictors of agreement between the two methods include gestational age, chronological age and mode of delivery. Further studies are needed to confirm this agreement in sick newborns and in extremely premature infants.
PMCID: PMC4156607  PMID: 25176563
Axillary temperature; Diagnostic accuracy; Newborn; Rectal temperature; Thermometry methods
3.  A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial 
BMC Public Health  2014;14:36.
Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates.
A multi-center randomized controlled trial. Study population: 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. Intervention: A “prenatal/postnatal” professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Outcome measures: Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Statistical analysis: Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS.
Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa (MENA) region.
Trial registration
Current Controlled Trials ISRCTN17875591
PMCID: PMC3898488  PMID: 24428951
Breastfeeding; Lay support; Cost analysis; Lactation support; Knowledge; Attitudes; Social network; Social support theory
4.  Impact of C-reactive protein test results on evidence-based decision-making in cases of bacterial infection 
BMC Pediatrics  2012;12:140.
C-reactive protein (CRP) is widely used to detect bacterial infection in children. We investigated the impact of CRP test results on decision-making and summarized the evidence base (EB) of CRP testing.
We collected information from the hospital records of 91 neonates with suspected sepsis and of 152 febrile children with suspected infection on the number of ordered CRP tests, the number of EB-CRP tests, and the impact of the test results on decision-making. CRP diagnostic accuracy studies focusing on pediatric infections were reviewed critically. The main outcomes were the proportion of CRP tests that were EB and the proportion of tests that affected decision-making. A secondary outcome was the overall one-year expenditure on CRP testing.
The current EB for CRP testing in pediatric infections is weak and suggests that CRP is of low diagnostic value. Approximately 54.8% of tests performed for suspected neonatal sepsis and 28% of tests performed for other infections were EB; however, the results of only 12.9% of neonatal sepsis tests and of 29.9% of tests on children with other infections informed decision-making. The one-year overall cost for CRP testing and related health care was $26,715.9.
The routine ordering of CRP for children with infections is based on weak evidence. The impact of the CRP test results on decision-making is rather small, and CRP ordering may contribute to unnecessary health care expenditures. Better quality research is needed to definitively determine the diagnostic accuracy of CRP levels in children with infections.
PMCID: PMC3457842  PMID: 22943554
C-reactive protein; Neonatal sepsis; Bacterial infection; Diagnostic accuracy
5.  Why are breastfeeding rates low in Lebanon? a qualitative study 
BMC Pediatrics  2011;11:75.
Breastfeeding is a cost-effective public health intervention that reduces infant morbidity and mortality in developing countries. In Lebanon, breastfeeding exclusivity and continuation rates are disappointingly low. This qualitative study aims at identifying barriers and promoters of breastfeeding in the Lebanese context by exploring mothers' perceptions and experiences in breastfeeding over a one year period.
We conducted focus group discussions in three hospitals in Beirut, Lebanon, and followed up 36 breastfeeding mothers with serial in-depth interviews for one year post-partum or until breastfeeding discontinuation.
Themes generated from baseline interviews revealed several positive and negative perceptions of breastfeeding. Longitudinal follow up identified insufficient milk, fear of weight gain or breast sagging, pain, sleep deprivation, exhaustion, or maternal employment, as reasons for early breastfeeding discontinuation. Women who continued breastfeeding for one year were more determined to succeed and overcome any barrier, relying mostly on family support and proper time management.
Increasing awareness of future mothers about breast feeding difficulties, its benefits to children, mothers, and society at large may further promote breastfeeding, and improve exclusivity and continuation rates in Lebanon. A national strategy for early intervention during school years to increase young women's awareness may improve their self-confidence and determination to succeed in breastfeeding later. Moreover, prolonging maternity leave, having day-care facilities at work, creation of lactation peer support groups and hotlines, and training of doctors and nurses in proper lactation support may positively impact breastfeeding exclusivity and continuation rates. Further research is needed to assess the effectiveness of proposed interventions in the Lebanese context.
PMCID: PMC3175169  PMID: 21878101
Breast feeding; Qualitative research; Lebanon
6.  When bone becomes marble: Head and neck manifestations of osteopetrosis 
Paediatrics & Child Health  2006;11(1):37-40.
Osteopetrosis is a genetically determined bone disease resulting from malfunction of osteoclastic activity, leading to excessive deposition of immature bone. This may result in complete agenesis of the paranasal sinuses, oral complications and multiple cranial neuropathies. The case of a 12-year-old boy with osteopetrosis is presented.
PMCID: PMC2435323  PMID: 19030245
Agenesis; Cartilage; Cheek swelling; Deafness; Osteopetrosis; Sinuses
7.  Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061] 
BMC Medicine  2006;4:4.
Alternating ibuprofen and acetaminophen for the treatment of febrile children is a prevalent practice among physicians and parents, despite the lack of evidence on effectiveness or safety. This randomized, double-blind and placebo-controlled clinical trial aims at comparing the antipyretic effectiveness and safety of a single administration of alternating ibuprofen and acetaminophen doses to that of ibuprofen mono-therapy in febrile children.
Seventy febrile children were randomly allocated to receive either a single oral dose of 10 mg/kg ibuprofen and 15 mg/kg oral acetaminophen after 4 hours, or a similar dose of ibuprofen and placebo at 4 hours. Rectal temperature was measured at baseline, 4, 5, 6, 7 and 8 hours later. Endpoints included proportions of afebrile children at 6, 7 and 8 hours, maximum decline in temperature, time to recurrence of fever, and change in temperature from baseline at each time point. Intent-to-treat analysis was planned with statistical significance set at P < 0.05.
A higher proportion of subjects in the intervention group (83.3%) became afebrile at 6 hours than in the control group (57.6%); P = 0.018. This difference was accentuated at 7 and 8 hours (P < 0.001) with a significantly longer time to recurrence of fever in the intervention group (mean ± SD of 7.4 ± 1.3 versus 5.7 ± 2.2 hours), P < 0.001. Odds ratios (95%CI) for defervescence were 5.6 (1.3; 23.8), 19.5 (3.5; 108.9) and 15.3 (3.4; 68.3) at 6, 7 and 8 hours respectively. Two-way ANOVA with repeated measures over time revealed a significantly larger decline in temperature in the intervention group at times 7 (P = 0.026) and 8 (P = 0.002) hours.
A single dose of alternating ibuprofen and acetaminophen appears to be a superior antipyretic regimen than ibuprofen mono-therapy. Further studies are needed to confirm these findings.
PMCID: PMC1421419  PMID: 16515705
8.  Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401] 
BMC Pediatrics  2005;5:35.
The antipyretic effectiveness of rectal versus oral acetaminophen is not well established. This study is designed to compare the antipyretic effectiveness of two rectal acetaminophen doses (15 mg/kg) and (35 mg/kg), to the standard oral dose of 15 mg/kg.
This is a randomized, double-dummy, double-blind study of 51 febrile children, receiving one of three regimens of a single acetaminophen dose: 15 mg/kg orally, 15 mg/kg rectally, or 35 mg/kg rectally. Rectal temperature was monitored at baseline and hourly for a total of six hours. The primary outcome of the study, time to maximum antipyresis, and the secondary outcome of time to temperature reduction by at least 1°C were analyzed by one-way ANOVA. Two-way ANOVA with repeated measures over time was used to compare the secondary outcome: change in temperature from baseline at times1, 2, 3, 4, 5, and 6 hours among the three groups. Intent-to-treat analysis was planned.
No significant differences were found among the three groups in the time to maximum antipyresis (overall mean = 3.6 hours; 95% CI: 3.2–4.0), time to fever reduction by 1°C or the mean hourly temperature from baseline to 6 hours following dose administration. Hypothermia (temperature < 36.5°C) occurred in 11(21.6%) subjects, with the highest proportion being in the rectal high-dose group.
Standard (15 mg/kg) oral, (15 mg/kg) rectal, and high-dose (35 mg/kg) rectal acetaminophen have similar antipyretic effectiveness.
PMCID: PMC1215489  PMID: 16143048
9.  Blood Lead Concentrations in 1–3 Year Old Lebanese Children: A Cross-sectional study 
Childhood lead poisoning has not made the list of national public health priorities in Lebanon. This study aims at identifying the prevalence and risk factors for elevated blood lead concentrations (B-Pb ≥ 100 μg/L) among 1–3 year old children. It also examines the need for universal blood lead screening.
This is a cross-sectional study of 281 well children, presenting to the pediatric ambulatory services at the American University of Beirut Medical Center in 1997–98. Blood was drawn on participating children for lead analysis and a structured questionnaire was introduced to mothers asking about social, demographic, and residence characteristics, as well as potential risk factors for lead exposure. Children with B-Pb ≥ 100 μg/L were compared to those with B-Pb < 100 μg/L.
Mean B-Pb was 66.0 μg/L (median 60.0; range 10–160; standard deviation 26.3) with 39 (14%) children with B-Pb ≥ 100 μg/L. Logistic regression analysis showed that elevated B-Pb was associated with paternal manual jobs (odds ratio [OR]: 4.74), residence being located in high traffic areas (OR: 4.59), summer season (OR: 4.39), using hot tap water for cooking (OR: 3.96), exposure to kohl (OR: 2.40), and living in older buildings (OR: 2.01).
Lead screening should be offered to high-risk children. With the recent ban of leaded gasoline in Lebanon, emphasis should shift to other sources of exposure in children.
PMCID: PMC156892  PMID: 12780938

Results 1-9 (9)