Abstract
BackgroundGlobally, 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.MethodsThis 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 registrationClinicalTrials.gov NCT03564652. Registered on 21 June 2018
Highlights
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)
Globally, approximately 45% of under-five deaths are attributable to childhood malnutrition, primarily in lowand middle-income countries (LMICs)
The primary objective is to compare the efficacy of fortified, balanced energy protein (BEP) supplements being consumed by lactating women for 6 months with or without a single prophylactic dose of oral azithromycin to the infant at 42 days of age with that of standard exclusive breastfeeding and nutritional counseling alone in improving the length velocity among infants at 6 months
Summary
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 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. Approximately 45% of under-five deaths are attributable to childhood malnutrition, primarily in lowand middle-income countries (LMICs). Children are vulnerable in the first 6 months of life, and globally, an estimated 4.7 million infants under the age of 6 months are moderately wasted and 3.8 million are severely wasted [2]. Inadequate maternal dietary intake during pregnancy and lactation is the single strongest predictor of stunting and underweight among children [11]. The implications in terms of child growth, development, and longterm health cannot be overstated [12, 13]
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