Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): an observational study

Abstract

BACKGROUND: Infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, timeline of protection, and benefit of CDKs in home and facility-based deliveries. METHODS AND FINDINGS: A post-hoc, secondary analysis was performed using non-randomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamp, plastic sheet, razor blade, matches, and candles, were provided to all participants. Field monitors made home-based visit to each participant 4 days post-partum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and newborn mortality rate (NMR).Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and missing information. Gloves, cord clamp, and plastic sheets were the most frequently used CDK item combinations in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus non-users. Adjusted logistic regression showed that use of gloves (OR: 0.33, CI: 0.24-0.46), cord clamp (OR: 0.51, CI: 0.38-0.68), plastic sheets (OR: 0.46, CI: 0.34-0.63), and razor blades (OR: 0.69, CI: 0.53-0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp was associated with reduced risk of immediate newborn death (<24 hours). Reduction in risk of early newborn death (1-7 days) was associated with use of gloves, cord clamp, plastic sheets, and razor blades. In examining perinatal mortality, similar patterns were observed. There was no significant reduction in risk of late newborn mortality (7-28 days) with CDK use. Study limitations included potential for potential recall bias of CDK use and inability to establish causality as a secondary observational study. CONCLUSIONS: CDK use was associated with reductions in early newborn mortality at both home and facility deliveries, especially when certain kit components were used. While causality could not be established in this non-randomized secondary analysis, given these beneficial associations, scaling up the use of CDKs in rural areas of sub-Saharan Africa may improve neonatal outcomes.