Ethics.
infantile hypertrophic pyloric stenosis
ADVERSE EVENTS, INFECTIOUS DISEASE
The trial was reviewed and approved by the Comité d’Ethique pour la Recherche en Santé in Ouagadougou (Protocol #2018-10-123) and the Institutional Review Board at the University of California, San Francisco (Protocol #18-25027). Written informed consent was obtained from the caregiver of each enrolled infant. The trial was overseen by a Data and Safety Monitoring Committee (DSMC) that consisted of independent experts in pediatric infectious disease, randomized controlled trials, mass azithromycin distribution, bioethics, and biostatistics. The DSMC reviewed quarterly data reports in aggregate and met face-to-face once annually to ensure participant safety, review trial progress and adverse events, and recommend continuation or discontinuation of the trial. Safety monitoring including measurement of caregiver-reported adverse events at each study visit and active surveillance for infantile hypertrophic pyloric stenosis. Full details are reported in the trial’s primary endpoint report.