%0 Journal Article
%T Effect of maternal post-natal Balanced Energy Protein supplementation and infant Azithromycin on infant growth outcomes- An Open-label randomized controlled trial.
%A Muhammad A
%A Shafiq Y
%A Nisar MI
%A Balouch B
%A Pasha A
%A Yazdani NS
%A Rizvi A
%A Sajid M
%A Jehan F
%J Am J Clin Nutr
%V 0
%N 0
%D 2024 Jun 24
%M 38925354
%F 8.472
%R 10.1016/j.ajcnut.2024.06.008
%X <B>BACKGROUND: </B>Maternal undernutrition is a direct risk factor for infant growth faltering.<BR><B>OBJECTIVE: </B>We evaluated the effect of postnatal Balanced Energy Protein (BEP) supplementation in lactating women and Azithromycin (AZ) in infants on infant growth outcomes.<BR><B>METHODS: </B>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 less than 23 cm and live infants between 0-6 days of life were randomly assigned to one of three 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 months of age. In intervention arm 1, mothers additionally received two 75-gram sachets of BEP per day, while in intervention arm 2 along with the standard-of-care and BEP, the infant also received one dose of Azithromycin (at 20 mg per kilogram) at 42 days of life. The primary outcome was infant length velocity at 6 months. The total sample size was 957 (319 in each arm).<BR><B>RESULTS: </B>From August 1, 2018 to May 19, 2020, 319 lactating mother-newborn dyads were randomized in each arm, and the last follow-up was completed on November 20, 2020. The mean difference in length velocity (cm per month) between BEP alone and control was 0.01 (95% 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) non-fatal events (injectable treatment and/or hospitalizations) were recorded.<BR><B>CONCLUSIONS: </B>Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 months, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.<BR><B>UNASSIGNED: </B>This trial is registered on ClinicalTrials.gov NCT03564652 on June 21, 2018.