Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan—the protocol for a multiarm assessor-blinded randomized controlled trial (Mumta LW trial)

Abstract

Background: Globally, 45% of under-five deaths are either directly or indirectly attributable to malnutrition, and most of these deaths are in low-and middle-income countries (LMICs). Children are particularly vulnerable in the first 6 months of life. An estimated 4.7 million infants under the age of 6 months are moderately wasted, whereas 3.8 million are severely wasted. Although the children of malnourished women have an increased risk of stunting and wasting, there is little information on this issue. Methods: This is a community-based, open-label, multiarm randomized controlled trial that will include parallel group assignments with a 1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. The women in the control group (control arm) will receive standard counseling only, whereas the lactating women in the first intervention group (intervention arm 1) will receive two sachets of balanced energy protein (BEP) supplementation per day from enrollment until the infant reaches 6 months of age. The lactating women in the second intervention group (intervention arm 2) will receive the same BEP supplementation as those in intervention arm 1 while their babies will also receive a single stat dose (20 mg/kg orally) of azithromycin at 42 days. The primary outcome will be the relative length velocity from 0 to 6 months by intervention arm. The primary analysis will be intention-to-treat analysis. Trial registration: ClinicalTrials.gov NCT03564652. Registered on

Routine antibiotics for infants less than 6 months of age with growth failure/faltering: a systematic review

“… 18 Two other studies could have been included; however, both included both nourished and malnourished participants, and we could not obtain the randomised data for our population of interest. 19 20 We also identified a recently completed trial 21 and requested the data for inclusion in this review; however, study investigators were submitting their results to a peer-review journal and are not yet willing to share those data.…”

Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses – finding and creating similarities in variables and data collection

“…The methods described here chronicle the initial phase of the initiative to harmonize selected variable definitions (including case definitions and outcomes) and develop research questions for IPD meta-analysis. Methods for individual studies are not part of the current paper but study registry information is included in Table 1 , and protocols are or will be published separately by the research team for each study [ 17 – 21 , 26 – 29 ]. The long-term goal of the initiative is to conduct prospective, IPD meta-analyses to examine the effects of maternal BEP supplementation on pregnancy and postpartum outcomes for mother and child.…”

“…Following this guidance, the BMGF funded several intervention studies planning to test the effect of BEP in preconception, pregnancy, and/or lactation in countries in South Asia and sub-Saharan Africa. These studies were all designed with BEP supplements that followed the nutrient content targets from the 2016 guidance [ 17 – 29 ], but had independent investigators and were not coordinating together. Studies were specifically funded in multiple countries, given that some heterogeneity across studies (e.g., different environmental factors, diets, and range of nutritional status) is helpful to find answers that can be applicable across diverse populations.…”

The effect of balanced energy-protein supplementation provided to lactating women on maternal and infant outcomes: study protocol for a prospectively planned individual patient data (IPD) meta-analysis

“…IMPRINT’s nutritional intervention was five different BEP snacks produced by a local company and a separate multiple micronutrient supplement ( Table 2 ) (18). The MumtaLW trial provided a BEP local product called Mumta that is fortified with multiple micronutrients; two sachets per day were provided (19). MumtaLW had a third intervention arm in which the women received BEP and the infants also received one dose of azithromycin at 42 days.…”