Chlorhexidine cleansing of the umbilical cord stump and risk of omphalitis and neonatal death

Abstract

Background: Sub-Saharan Africa and South Asia account for 80% of all neonatal deaths in the world. In these two regions, infectious diseases account for one third of neonatal deaths. Early neonatal sepsis is a major contributor to the high neonatal morbidity and mortality and umbilical cord stump infection (omphalitis) is postulated to be a potential precursor to neonatal sepsis. There has been evidence from Asia to suggest that CHX application to the umbilical cord stump can reduce the risk of omphalitis as well as neonatal death. No data on the efficacy of CHX cord care in Africa were available before we embarked on the studies described in this thesis. The studies in this thesis address four main topics: i) understanding childbirth and newborn care knowledge, attitudes and practices (KAP); ii) feasibility, acceptance and compliance with different modes of CHX application on the umbilical cord stump; iii) effect of the proposed CHX formulation on bacterial colonization of the cord stump; and iv) efficacy of CHX application on the risk of omphalitis and neonatal death. Methods: Two qualitative studies were conducted in Pemba, a part of the Zanzibar archipelago of Tanzania. The first study explored the KAP regarding childbirth, newborn and umbilical cord care and probed barriers and facilitators to introduction of CHX cord care. A total of 80 in-depth interviews (IDIs) and 11 focus group discussions (FGDs) involving mothers, grandmothers, fathers, traditional birth attendants (TBAs) and health service providers were undertaken. A second study, using the Trials of Improved Practices (TIPs) methodology investigated the feasibility, acceptance, and compliance with three possible modes of CHX application. The third study tested the effect of a commercially prepared 4% CHX solution on bacterial colonization in New Delhi. The fourth study was a large community-based randomized control trial (RCT) in Pemba to estimate the efficacy of CHX cleansing of the umbilical cord stump on the risk of omphalitis and neonatal death. The RCT was implemented in two phases. During Phase 1, the study participants were randomly allocated to one of three intervention arms: the treatment arm using CHX, one control arm using a placebo solution and a second control arm practicing dry cord care. During Phase 2, the placebo arm of the trial was dropped, and the participants were randomized to receive either CHX or dry cord care. For babies allocated to the CHX and the placebo arms, mothers/caregivers were advised to apply the solution to the cord stump every day until 3 days after the cord stump had fallen off. For babies assigned to the dry cord care arm, TBAs and hospital staff instructed the mothers/caregivers not to cleanse the umbilical cord stump and to keep it dry. In all trial arms, the cord was examined for redness, pus, swelling and/or foul smell on days 0, 1, 4, 10 and 28. Findings: The qualitative study showed that the awareness among the community members regarding the importance of facility-based births was high. However, impediments such as lack of transportation; cost of medicines and quality of care at the facilities seemed to be a reason for many women choosing to give birth at home. Some of the reported good practices included use of clean delivery instruments, TBAs’ emotional and physical support to mothers, newborn warming and feeding of colostrum. Some behaviors that could undermine newborn health, such as immediate bathing of newborns, poor hand hygiene of TBAs, exposing the newborn to smoke for warming, application of some traditional substances on the cord stump were also reported by some participants. CHX cord stump cleansing was an acceptable and feasible intervention and could be easily applied by family members after some initial training. The second study revealed that mothers and health service providers preferred a single use dropper bottle for CHX application as compared to either a 100 ml multiple use bottle with cotton swabs or a gel tube. The third study showed that cord stump cleansing with 4% CHX soon after birth substantially reduced bacterial colonization. The large efficacy trial found that CHX cleansing resulted in a large reduction in the risk of omphalitis (Relative risk (RR): 0.65; 95% Confidence interval (CI) 0.61 to 0.70). The mortality in the dry cord care arm was lower than anticipated, and any effect of CHX on neonatal mortality was small (RR: 0.90; 95% CI 0.74 to 1.09). Any effect of CHX application on the risk of death did not differ by whether the babies were born at home (RR: 0.92; 95% CI 0.67 to 1.27) or in a health facility (RR: 0.89; 95% CI 0.70 to 1.14). Conclusion: CHX cleansing of the cord stump, while acceptable to mothers and families markedly reduced the risk of omphalitis but this reduction did not translate into a substantial decrease in the risk of neonatal death in this East African setting