Elsevier

The Lancet

Volume 379, Issue 9820, 17–23 March 2012, Pages 1029-1036
The Lancet

Articles
Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial

https://doi.org/10.1016/S0140-6736(11)61877-1Get rights and content

Summary

Background

Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.

Methods

We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.

Findings

187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41–0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61–1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45–0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79–1·48; p=0·62). We recorded no serious adverse events.

Interpretation

Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.

Funding

The United States Agency for International Development.

Introduction

Of the 3·3 million annual neonatal deaths that occur worldwide, more than 99% occur in low-income and middle-income countries and about a third are attributed to infections.1 Infection risk is greatest in countries where most deliveries (>70%) take place at home, often attended by unskilled traditional birth attendants (TBAs) with suboptimal conditions and delivery practices.2, 3 Compounding these problems are high rates of low birthweight and preterm birth, often associated with increased risk of infections.4

Pakistan has one of the highest neonatal mortality rates in the world (53 deaths per 10 000 livebirths) and up to 30% of neonatal deaths in Pakistan are attributed to sepsis.5 Unsafe practices such as cutting the umbilical cord with unsterilised instruments and application of substances such as ash, lead-based concoctions (known locally as surma), oil, and, rarely, cow dung are practised in many rural areas of Pakistan6 and associated with high risk of neonatal sepsis and mortality.7 A range of available approaches have the potential to reduce the risk of neonatal infections. These include hygiene promotion (including handwashing), skin cleansing with antiseptics such as chlorhexidine (CHX), and promotion and use of clean birth kits. However, other than handwashing, provision of clean birth kits, and early initiation of breastfeeding, no other intervention to prevent neonatal infections is recommended for large scale implementation.8, 9, 10, 11

Cord care is an important component of immediate neonatal care. On the basis of the findings of a Cochrane review by Zupan and colleagues,12 WHO recommends dry care of the neonatal umbilical cord. The Cochrane review included 22 trials with a total of 8959 babies and examined various types of antiseptics applied to the umbilical cord. All the included studies were done in hospital settings and, with the exception of one trial from Thailand,13 in high-income countries. No systemic infections or deaths were reported in any of the trials and no differences in risk of umbilical cord infection were identified when the use of a topical antiseptic was compared with dry cord care or placebo, resulting in the recommendation of dry cord care. However, the validity of this recommendation for community settings in low-income countries, where the prevalence and risks of cord infection are much higher,3 is questionable.

A community-based effectiveness trial of the application of CHX to the umbilical cord in Nepal14 reported promising results with 75% reduction in the incidence of severe omphalitis and 24% reduction in neonatal mortality in infants who received topical CHX as opposed to dry cord care. Handwashing with soap has also shown promising results in community settings.15, 16 A cohort study from Nepal reported reduced risks of neonatal mortality associated with birth-attendant handwashing (relative risk [RR]=0·81, 95% CI 0·66–0·99), maternal handwashing (RR=0·56, 0·38–0·82), and when handwashing was practised by both the mother and birth attendant (RR=0·59, 0·37–0·94).8

Neither of these studies were done in health systems that used feasible and cost-effective delivery strategies and existing resources. We therefore designed an effectiveness trial to assess the feasibility of cleansing the umbilical cord with 4% CHX solution with or without handwashing with antiseptic soap, and to assess the effect of promotion of these interventions through TBAs on the incidence of omphalitis and neonatal mortality.

Section snippets

Study area and population

We did a cluster-randomised trial in Dadu, a resource-poor rural district in Sindh province, Pakistan, with a population of about 1 million people and an infant mortality rate of 90 per 1000 livebirths.17 Most (>80%) deliveries in the district are done at home by TBAs. The study interventions were delivered at the household level by TBAs working under the supervision of locally recruited community health workers (CHWs). All newborn babies delivered participating TBAs were eligible for enrolment

Results

Between January, 2008, and June, 2009, 11 886 livebirths were reported from the study area, of which 2145 were excluded; we enrolled 9741 babies into the trial (figure 1). Baseline socioeconomic, household, and maternal characteristics were much the same between the four groups (table 1). Almost 90% of households (7213 of 8290) practiced application of traditional substances (oil, surma, coal) on the cord.

Most (2118 [97%]) care providers of enrolled infants in groups A and C reported at least

Discussion

Our findings shows that the application of CHX to the umbilical cord of a newborn baby can reduce the incidence of neonatal omphalitis and neonatal mortality compared with the recommendation to families of dry cord care or handwashing only. The umbilical cord of a newborn baby is easily colonised by microorganisms and bacteria.23 The rate of bacterial colonisation in the early neonatal period is closely related with the incidence of neonatal sepsis,24, 25, 26 suggesting the need for early

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