Screening, randomization, and follow-up of participants in a trial of azithromycin for infants aged 5–12 weeks of age.

Screening, randomization, and follow-up of participants in a trial of azithromycin for infants aged 5–12 weeks of age.</p

Wasting, underweight, and stunting by randomized treatment group.

Wasting, underweight, and stunting by randomized treatment group.</p

Baseline characteristics by randomized treatment group.

Baseline characteristics by randomized treatment group.</p

Supporting data tables.

Table A. Baseline characteristics among infants included in the analysis (N = 27,743) and not included in the analysis (N = 5,134) by randomized treatment assignment. Table B. Results of subgroup analyses for each outcome at 6 months of age by age at enrollment in months. Table C. Results of subgroup analyses for each outcome at 6 months of age by child’s sex. Table D. Results of subgroup analyses for each outcome at 6 months of age by season of enrollment. Table E. Results of subgroup analyses for each outcome at 6 months of age by underweight (weight-for-age Z-score Table F. Results of subgroup analyses for each outcome at 6 months of age by wasting (weight-for-length Z-score Table G. Results of subgroup analyses for each outcome at 6 months of age by stunting (height-for-length Z-score (DOCX)</p

Statistical analysis plan for the trial.

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.govNCT03676764</div

Differences in categorical anthropometric endpoints at 6 months of age in azithromycin compared to placebo among subgroups of infants defined by age at enrollment (grey bars), season of enrollment (orange bars), sex (blue bars), stunting (green bars), underweight (yellow bars), and wasting (black bars).

Outcomes include underweight (WAZ, A), stunting (LAZ, B), wasting (WLZ, C), and wasting by MUAC (MUAC D). For each outcome, n represented the number of infants with the outcome at 6 months in each randomized treatment arm, and N represents the total number of infants contributing to the subgroup. LAZ, length-for-age Z-score; MUAC, mid-upper arm circumference; WAZ, weight-for-age Z-score; WLZ, weight-for-length Z-score.</p

Anthropometric outcomes by randomized treatment group.

Anthropometric outcomes by randomized treatment group.</p

Differences in continuous anthropometric endpoints at 6 months of age in azithromycin compared to placebo among subgroups of infants defined by age at enrollment (grey bars), season of enrollment (orange bars), sex (blue bars), stunting (green bars), underweight (yellow bars), and wasting (black bars).

Outcomes include weight gain in g/day (A), length change in mm/day (B), MUAC in cm (C), WAZ (D), LAZ (E), and WLZ (F). Means indicate mean value for the outcome in each subgroup by treatment arm, and N indicates the number of infants in each subgroup in each treatment arm. Mean differences for each outcome can be found in S1 Appendix. LAZ, length-for-age Z-score; MUAC, mid-upper arm circumference; WAZ, weight-for-age Z-score; WLZ, weight-for-length Z-score.</p

Overview of asset possession and the calculated socioeconomic status among 187 adults in rural Côte d'Ivoire.

<p>Overview of asset possession and the calculated socioeconomic status among 187 adults interviewed in the Taabo health demographic surveillance system, south-central Côte d'Ivoire, in June 2010.</p>a<p>Reports the average number of people per sleeping room in the respective wealth quintile.</p

Handheld and mobile phone based microscopes.

<p>(A) The Newton Nm1-600 XY portable field microscope. (B) The reversed-lens CellScope attached to an iPhone 5s.</p