Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: An open-label randomized controlled trial
Document Type
Article
Department
Community Health Sciences; Paediatrics and Child Health; Center of Excellence for Trauma and Emergencies; Centre of Excellence in Women and Child Health
Abstract
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 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 to the mother, 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.
Publication (Name of Journal)
The American Journal of Clinical Nutrition
DOI
10.1016/j.ajcnut.2024.06.008
Recommended Citation
Muhammad, A.,
Shafiq, Y.,
Nisar, M. I.,
Baloch, B.,
Pasha, A.,
Yazdani, N. S.,
Rizvi, A.,
Muhammad, S.,
Jehan, F.
(2024). Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: An open-label randomized controlled trial. The American Journal of Clinical Nutrition, 120(3), 550-559.
Available at:
https://ecommons.aku.edu/cete/1