Impact of Umbilical Cord Cleansing with Chlorhexidine on Neonatal Mortality and Omphalitis in Bangl
Start Date: 10/01/2006
End Date: 09/30/2011
This two-phase study will evaluate the impact of umbilical cord cleansing with chlorhexidine in Sylhet District, Bangladesh. The design and methods for this study will build upon the already existing infrastructure and capacity of personnel currently working in Projahnmo, thus providing considerable cost savings. The first phase of this project will entail two distinct activities: a) scaling up of essential newborn care activities currently being evaluated to the entire Sylhet trial areas including the current comparison clusters and b) formative research to develop strategies to deliver the new intervention (chlorhexidine cleansing of the umbilical cord). The implementation of the essential newborn care program will form the foundation upon which the proposed chlorhexidine trial will be conducted. The formative research on chlorhexidine cleansing of the cord will provide information crucial for implementation of the second phase of the study. In order to move toward a delivery model based on minimally trained community health workers, several outstanding issues must be explored. Combining this contextual understanding with family members' attitudes towards incorporation of chlorhexidine cleansing of the cord and exploration of various potential formulations of chlorhexidine will allow development of appropriate behavior change messages that will support the compliance with the intervention in phase II. Furthermore, different models for packaging and delivery of chlorhexidine for routine implementation must also be explored. In Phase II, the Intervention Trial, the study has been designed as a community-based, double-masked, cluster-randomized trial. The two primary outcomes of this trial will be neonatal mortality and omphalitis among live born infants.