Evidence map›Paper›PMID 38925354›Full record

Trial reportThe American journal of clinical nutrition2024

Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial.

Ameer Muhammad, Yasir Shafiq, Muhammad Imran Nisar, Benazir Baloch, Aneela Pasha, Nida Salman Yazdani, Arjumand Rizvi, Sajid Muhammad, Fyezah Jehan

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03564652 (Nutritional Support for Lactating Women and Azithromycin to Infants to Improve Growth Outcomes in Peri-urban Slums of Karachi, Pakistan - Randomized Controlled Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03564652 nacompletednot on this map

Nutritional Support for Lactating Women and Azithromycin to Infants to Improve Growth Outcomes in Peri-urban Slums of Karachi, Pakistan - Randomized Controlled Trial

TypeinterventionalSponsorVital Pakistan TrustRan2018 to 2020Enrolled957ConditionsUndernutritionArmsBalanced energy-protein (BEP), Azithromycin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Effect of one prophylactic dose of azithromycin on Bifidobacterium infantis colonization in infants from the Mumta trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ameer MuhammadVaccines and Other Initiatives to Advance Lives (VITAL) Pakistan Trust, Karachi, Pakistan.
Yasir ShafiqCenter of Excellence for Trauma and Emergencies and Community Health Sciences, The Aga Khan University, Karachi, Pakistan; Global Advancement of Infants and Mothers (AIM), Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Harvard T. H. Chan School of Public Health, Boston, MA, United States; Center for Research and Training in Disaster Medicine, Humanitarian Aid and Global Health (CRIMEDIM), Università degli Studi del Piemonte Orientale "Amedeo Avogadro," Vercelli, Italy.
Muhammad Imran NisarDepartment of Pediatrics and Child Health Medical College, The Aga Khan University, Karachi, Pakistan.
Benazir BalochDepartment of Pediatrics and Child Health Medical College, The Aga Khan University, Karachi, Pakistan.
Aneela PashaDepartment of Pediatrics and Child Health Medical College, The Aga Khan University, Karachi, Pakistan.
Nida Salman YazdaniVaccines and Other Initiatives to Advance Lives (VITAL) Pakistan Trust, Karachi, Pakistan.
Arjumand RizviCentre of Excellence in Maternal and Child Health, The Aga Khan University, Karachi, Pakistan.
Sajid MuhammadCentre of Excellence in Maternal and Child Health, The Aga Khan University, Karachi, Pakistan.
Fyezah JehanDepartment of Pediatrics and Child Health Medical College, The Aga Khan University, Karachi, Pakistan. Electronic address: fyezah.jehan@aku.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaternal undernutrition is a direct risk factor for infant growth faltering.

objectivesWe evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes.

methodsA 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 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).

resultsFrom 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.

conclusionsPostnatal 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.

Indexed as

AzithromycinDietary SupplementsAdultAnti-Bacterial AgentsBreast FeedingChild DevelopmentDietary ProteinsFemaleHumansInfantInfant, NewbornInfant Nutritional Physiological PhenomenaLactationMaleMaternal Nutritional Physiological PhenomenaPakistanAnti-Bacterial AgentsAzithromycinDietary Proteinsanthropometryazithromycinbalanced energy protein supplementschild growthexclusive breastfeedinglactating mothers

Identifiers

PMID38925354
PMCPMC11393397

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.