Abstract
Background: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are higher risk and take protective measures. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9cm cut-off performed relatively well, differentiating normal from low birthweight.Methods: Community-based, cluster-randomized controlled trial. Objective: to determine whether family-administered screening, with targeted messages improves care practices known to mitigate LBWt risks. Participants: pregnant women participating in a parent trial in rural Nepal. Women were given a 6.9cm card to assess whether the baby’s foot is small; if so, to call number on the card for advice. Follow-up visits were made over 2 weeks following the birth, assessing for: reported skin-to-skin thermal care, and care-seeking outside the home; restricting to low birthweight (using 2 cutoffs: 2,500g and 2,000g). Randomization: 17 clusters intervention, 17 control. The study also documented steps along the presumed causal chain from intervention through behavioral impact.Results: 2,022 into intervention, 2,432 into control. Intervention arm: 519 with birthweight <2,500g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference on care-seeking; for those <2,500g RR 1.13 (95%CI: 0.97-1.131). More of those in the intervention arm reported skin-to-skin thermal care than among controls; for those <2,500g RR 2.50 (95%CI: 2.01-3.1). Process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those <2,000 as normal.Conclusions: Although the trial found an apparent effect on one key behavioral outcome, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying at-risk babies in such settings, and targeting them for appropriate care messaging.Trial registration : clinicaltrials.gov identifier: NCT02802332, registered 16 June 2016, https://clinicaltrials.gov/ct2/show/NCT02802332
Extended Traditional Holding (TH) and Skin-to-Skin Care (SSC) for Newborn Infants ≤1500 grams. A Randomized Controlled Trial. Results of an Interim Analysis † 1115
