Vitality in Infants Via Azithromycin for Neonates Trial
Status:
Not yet recruiting
Trial end date:
2026-07-31
Target enrollment:
Participant gender:
Summary
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in
babies with low birthweight. Although tremendous progress has been made towards reducing
under-five mortality globally, declines in neonatal mortality lag behind those observed in
older children. Low birthweight babies are at increased risk of poor outcomes compared to
those who are term-appropriate for gestational age, including mortality, stunting, and growth
failure. Recent evidence has demonstrated that the incidence of wasting and linear growth
failure is highest between birth and 3 months of age, substantially earlier than previously
thought. Interventions are urgently needed to improve outcomes in low birthweight babies;
however, these interventions must not interfere with breastfeeding and thus some
well-established interventions used to treat or prevent malnutrition in older children cannot
be considered. The investigators recently demonstrated that biannual mass azithromycin
distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5
months, with stronger effects seen in underweight infants. This study did not include
neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been
hypothesized to be associated with macrolide use during early infancy. However, our study
team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of
azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant
mortality, documenting no major risk of IHPS associated with azithromycin. Here, the
investigators propose an individually randomized trial where participants will receive a
single oral dose of azithromycin (administered either during the neontal period or 21 days
after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of
placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden
among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or
underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be
weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate
that the results of this study will provide definitive evidence on azithromycin as an early
intervention for low birthweight/underweight neonates, who are at the highest risk of adverse
outcomes.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso