Recruitment and eligibility criteria.
infantile hypertrophic pyloric stenosis, allergies
NEONATAL JAUNDICE, ALLERGIES
Caregivers of newborns born at participating facilities and those bringing their children for routine vaccination days were informed of the study and how to participate. At participating facilities, BCG vaccination typically occurs during the weeks after birth rather than at birth. Those who were interested in the study were referred to the facility’s study nurse for formal eligibility assessment and enrollment. Neonates were eligible if they were between 8 and 27 days old at the time of enrollment, weight at least 2,500 g, had no known allergies to azalides or macrolides, were able to feed orally, and had no clinical signs of neonatal jaundice. Neonates who were too young or too small at their first evaluation could return for a second assessment once they had aged into the eligible age range or had grown for possible inclusion, provided they still met all eligibility criteria. Infants weighing less than 2,500 g at enrollment were excluded from the trial at the recommendation of the trial’s DSMC due to concerns that very small babies may be at increased risk of infantile hypertrophic pyloric stenosis.