Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomised controlled trial (Mumta LW trial)

Abstract Introduction Globally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child in a mother with nutritional decompensation, there are discrepancies in guidance in this area. Methods and analysis This is a community-based, open label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low income squatter settlements of urban Karachi, Pakistan. In the controls (Arm 1), women are randomized to standard counseling only; in first intervention group (Arm 2), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from delivery until the infant reaches six months of age. In second intervention group (Arm 3), lactating women receive same BEP as in intervention arm 1 and their babies receive single dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by limb of allocation. Primary analysis will be Intention-to-treat analysis Trial registration This trial was registered at ClinicalTrials.gov with the number NCT03564652 on June 21, 2018. The trial registration data are available through https://clinicaltrials.gov/ct2/show/NCT03564652.