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Effect of Antibiotics on Short-Term Growth among Children in Burkina Faso: A Randomized Trial.

ABSTRACT: Antibiotics improve both weight and height gain in randomized trials of preschool children with preexisting morbidity. Here, we assess the effect of a short course of three different antibiotics (amoxicillin, azithromycin, and cotrimoxazole) on short-term linear and ponderal growth in a population-based sample of preschool children in rural Burkina Faso. We randomized households with at least two children in the Nouna district, Burkina Faso, to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic-randomized household, one child was randomly assigned to receive the antibiotic and the other to receive the placebo. Weight and height measurements were taken at baseline and 30 days following the last study medication dose. Weight-for-height Z (WHZ), height-for-age Z (HAZ), and weight-for-age Z (WAZ) scoreswere calculated based on the 2006 World Health Organization standards. Of the 124 households and 248 children enrolled, 229 had anthropometry measurements at 1 month and were analyzed. Children randomized to amoxicillin gained significantly more weight compared with both the placebo household (mean difference 317 g, 95% confidence interval [CI]: 115-519 g) and placebo sibling (mean difference 315 g, 95% CI: 147-482 g) controls. Growth velocity in g/kg/day, and WHZ and WAZ scores were higher in amoxicillin-treated children compared with placebo households and siblings. There were no differences in weight gain in children randomized to azithromycin or cotrimoxazole compared with placebo households or placebo siblings. There were no differences in height gain or HAZ across any of the study arms. Amoxicillin may have short-term growth-promoting effects in healthy children.

SUBMITTER: Sie A

PROVIDER: S-EPMC6169163 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Effect of Antibiotics on Short-Term Growth among Children in Burkina Faso: A Randomized Trial.

Sié Ali A Dah Clarisse C Ouermi Lucienne L Tapsoba Charlemagne C Zabre Pascal P Bärnighausen Till T Lebas Elodie E Arzika Ahmed M AM Snyder Blake M BM Porco Travis C TC Lietman Thomas M TM Keenan Jeremy D JD Oldenburg Catherine E CE

The American journal of tropical medicine and hygiene 20180712 3

Antibiotics improve both weight and height gain in randomized trials of preschool children with preexisting morbidity. Here, we assess the effect of a short course of three different antibiotics (amoxicillin, azithromycin, and cotrimoxazole) on short-term linear and ponderal growth in a population-based sample of preschool children in rural Burkina Faso. We randomized households with at least two children in the Nouna district, Burkina Faso, to a 5-day course of amoxicillin, azithromycin, cotrim ...[more]

PMID: 30014828

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Project description:BackgroundAzithromycin is a broad-spectrum antibiotic that has moderate antimalarial activity and has been shown to reduce all-cause mortality when biannually administered to children under five in high mortality settings in sub-Saharan Africa. One potential mechanism for this observed reduction in mortality is via a reduction in malaria transmission.MethodsWe evaluated whether a single oral dose of azithromycin reduces malaria positivity by rapid diagnostic test (RDT). We conducted an individually randomized placebo-controlled trial in Burkina Faso during the high malaria transmission season in August 2020. Children aged 8 days to 59 months old were randomized to a single oral dose of azithromycin (20 mg/kg) or matching placebo. At baseline and 14 days following treatment, we administered a rapid diagnostic test (RDT) to detect Plasmodium falciparum and measured tympanic temperature for all children. Caregiver-reported adverse events and clinic visits were recorded at the day 14 visit.ResultsWe enrolled 449 children with 221 randomized to azithromycin and 228 to placebo. The median age was 32 months and 48% were female. A total of 8% of children had a positive RDT for malaria at baseline and 11% had a fever (tympanic temperature ≥ 37.5 °C). In the azithromycin arm, 8% of children had a positive RDT for malaria at 14 days compared to 7% in the placebo arm (P = 0.65). Fifteen percent of children in the azithromycin arm had a fever ≥ 37.5 °C compared to 21% in the placebo arm (P = 0.12). Caregivers of children in the azithromycin group had lower odds of reporting fever as an adverse event compared to children in the placebo group (OR 0.41, 95% CI 0.18-0.96, P = 0.04). Caregiver-reported clinic visits were uncommon, and there were no observed differences between arms (P = 0.32).ConclusionsWe did not find evidence that a single oral dose of azithromycin reduced malaria positivity during the high transmission season. Caregiver-reported fever occurred less often in children receiving azithromycin compared to placebo, indicating that azithromycin may have some effect on non-malarial infections. Trial registration Clinicaltrials.gov NCT04315272, registered 19/03/2020.

Project description:BackgroundAntibiotic use during early infancy has been linked to childhood obesity in high-income countries. We evaluated whether a single oral dose of azithromycin administered during infant-well visits led to changes in infant growth outcomes at 6 months of age in a setting with a high prevalence of undernutrition in rural Burkina Faso.Methods and findingsInfants were enrolled from September 25, 2019, until October 22, 2022, in a randomized controlled trial designed to evaluate the efficacy of a single oral dose of azithromycin (20 mg/kg) compared to placebo when administered during well-child visits for prevention of infant mortality. The trial found no evidence of a difference in the primary endpoint. This paper presents prespecified secondary anthropometric endpoints including weight gain (g/day), height change (mm/day), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and mid-upper arm circumference (MUAC). Infants were eligible for the trial if they were between 5 and 12 weeks of age, able to orally feed, and their families were planning to remain in the study area for the duration of the study. Anthropometric measurements were collected at enrollment (5 to 12 weeks of age) and 6 months of age. Among 32,877 infants enrolled in the trial, 27,298 (83%) were followed and had valid anthropometric measurements at 6 months of age. We found no evidence of a difference in weight gain (mean difference 0.03 g/day, 95% confidence interval (CI) -0.12 to 0.18), height change (mean difference 0.004 mm/day, 95% CI -0.05 to 0.06), WAZ (mean difference -0.004 SD, 95% CI -0.03 to 0.02), WLZ (mean difference 0.001 SD, 95% CI -0.03 to 0.03), LAZ (mean difference -0.005 SD, 95% CI -0.03 to 0.02), or MUAC (mean difference 0.01 cm, 95% CI -0.01 to 0.04). The primary limitation of the trial was that measurements were only collected at enrollment and 6 months of age, precluding assessment of shorter-term or long-term changes in growth.ConclusionsSingle-dose azithromycin does not appear to affect weight and height outcomes when administered during early infancy.Trial registrationClinicalTrials.gov NCT03676764.

Project description:BackgroundIn Burkina Faso, facility-based caesarean delivery rates have markedly increased since the national subsidy policy for deliveries and emergency obstetric care was implemented in 2006. Effective and safe strategies are needed to prevent unnecessary caesarean deliveries.MethodsWe conducted a cluster-randomized controlled trial of a multifaceted intervention at 22 referral hospitals in Burkina Faso. The evidence-based intervention was designed to promote the use of clinical algorithms for caesarean decision-making using in-site training, audits and feedback of caesarean indications and SMS reminders. The primary outcome was the change in the percentage of unnecessary caesarean deliveries. Unnecessary caesareans were defined on the basis of the literature review and expert consensus. Data were collected daily using a standardized questionnaire, in the same way at both the intervention and control hospitals. Caesareans were classified as necessary or unnecessary in the same way, in both arms of the trial using a standardized computer algorithm.ResultsA total of 2138 and 2036 women who delivered by caesarean section were analysed in the pre and post-intervention periods, respectively. A significant reduction in the percentage of unnecessary caesarean deliveries was evident from the pre- to post-intervention period in the intervention group compared with the control group (18.96 to 6.56% and 18.27 to 23.30% in the intervention and control groups, respectively; odds ratio [OR] for incremental change over time, adjusted for hospital and patient characteristics, 0.22; 95% confidence interval [CI], 0.14 to 0.34; P < 0.001; adjusted risk difference, - 17.02%; 95% CI, - 19.20 to - 13.20%). The intervention did not significantly affect the rate of maternal death (0.75 to 0.19% and 0.92 to 0.40% in the intervention and control groups, respectively; adjusted OR 0.32; 95% CI 0.04 to 2.23; P = 0.253) or intrapartum-related neonatal death (4.95 to 6.32% and 5.80 to 4.29% in the intervention and control groups, respectively, adjusted OR 1.73; 95% CI 0.82 to 3.66; P = 0.149). The overall perinatal mortality data were not available.ConclusionPromotion and training on clinical algorithms for decision-making, audit and feedback and SMS reminders reduced unnecessary caesarean deliveries, compared with usual care in a low-resource setting.Trial registrationThe DECIDE trial is registered on the Current Controlled Trials website: ISRCTN48510263 .

Dataset Information

Effect of Antibiotics on Short-Term Growth among Children in Burkina Faso: A Randomized Trial.

Publications

Effect of Antibiotics on Short-Term Growth among Children in Burkina Faso: A Randomized Trial.

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