1. Neonatal Azithromycin Administration and Growth during Infancy: A Randomized Controlled Trial
- Author
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Sie, Ali, Bountogo, Mamadou, Zakane, Alphonse, Compaoré, Guillaume, Ouedraogo, Thierry, Ouattara, Mamadou, Lebas, Elodie, Brogdon, Jessica, Nyatigo, Fanice, O’Brien, Kieran S, Porco, Travis C, Bärnighausen, Till, Arnold, Benjamin F, Lietman, Thomas M, Oldenburg, Catherine E, and Team, for the NAITRE Study
- Subjects
Infant Mortality ,Clinical Trials and Supportive Activities ,Clinical Research ,Nutrition ,Perinatal Period - Conditions Originating in Perinatal Period ,Obesity ,Pediatric ,Prevention ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Infant ,Newborn ,Child ,Infant ,Humans ,Female ,Male ,Azithromycin ,Pediatric Obesity ,Weight Gain ,Anti-Bacterial Agents ,Burkina Faso ,NAITRE Study Team ,Medical and Health Sciences ,Tropical Medicine - Abstract
Observational studies have linked early-life antibiotic exposure to increased risk of obesity in children in high income settings. We evaluated whether neonatal antibiotic exposure led to changes in infant growth at 6 months of age in Burkina Faso. Neonates aged 8 to 27 days of age who weighed at least 2,500 g at the time of enrollment were randomized in a 1:1 fashion to a single oral 20-mg/kg dose of azithromycin or equivalent volume of placebo from April 2019 through December 2020. Weight, length, and mid-upper-arm circumference (MUAC) were measured at baseline and 6 months of age. Growth outcomes, including weight gain in grams per day, length change in millimeters per day, and changes in weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and MUAC were compared among neonates randomized to azithromycin compared with placebo. Among 21,832 neonates enrolled in the trial, median age at enrollment was 11 days, and 50% were female. We found no evidence of a difference in weight gain (mean difference -0.009 g/day, 95% confidence interval [CI]: -0.16 to 0.14, P = 0.90), length change (mean difference 0.003 mm/day, 95% CI: -0.002 to 0.007, P = 0.23), or WAZ (mean difference -0.005 SD, 95% CI: -0.03 to 0.02, P = 0.72), WLZ (mean difference -0.01 SD, 95% CI: -0.05 to 0.02, P = 0.39), LAZ (mean difference 0.01, 95% CI: -0.02 to 0.04, P = 0.47), or MUAC (mean difference 0.01 cm, 95% CI: -0.02 to 0.04, P = 0.49). These results do not suggest that azithromycin has growth-promoting properties in infants when administered during the neonatal period. Trial registration: ClinicalTrials.gov NCT03682653.
- Published
- 2023