Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial.
Am J Clin Nutr
; 120(3): 550-559, 2024 Sep.
Article
en En
| MEDLINE
| ID: mdl-38925354
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 <23 cm and live infants between 0 and 6 d of life were randomly assigned to 1 of 3 arms in a 111 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 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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Azitromicina
/
Suplementos Dietéticos
Límite:
Adult
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Female
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Humans
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Infant
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Male
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Newborn
País/Región como asunto:
Asia
Idioma:
En
Revista:
Am J Clin Nutr
Año:
2024
Tipo del documento:
Article
País de afiliación:
Pakistán
Pais de publicación:
Estados Unidos