Effect of Maternal Post-Natal Balanced Energy Protein Supplementation and Infant Azithromycin on Infant Growth Outcomes- an Open-label Randomized Controlled Trial

Background Maternal undernutrition is a direct risk factor for infant growth faltering. Objectives We evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes. Methods A randomized controlled superiority trial of lactating mother–newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of <23 cm and live infants between 0 and 6 d of life were randomly assigned to 1 of 3 arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization, and health promotion plus iron-folate supplementation until the infant was 6 mo old. In intervention arm 1, mothers additionally received two 75-g sachets of BEP per day. In intervention arm 2, along with the standard-of-care and BEP, the infant also received 1 dose of azithromycin (20 mg/kg) at the age of 42 d . The primary outcome was infant length velocity at 6 mo. The total sample size was 957 (319 in each arm). Results From 1 August, 2018 to 19 May, 2020, 319 lactating mother–newborn dyads were randomly assigned in each arm, and the last follow-up was completed on 20 November, 2020. The mean difference in length velocity (cm/mo) between BEP alone and control was 0.01 (95% confidence interval [CI]: −0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI: 0.03, 0.13), and between BEP + AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) nonfatal events (injectable treatment and/or hospitalizations) were recorded. Conclusions Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 mo, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.This trial was registered at clinicaltrials.gov as NCT03564652.