The long-term objective of our research program is to identify cost-effective interventions that can significantly reduce morbidity and mortality among young children in the least developed areas of the world.
The aims of this project are focused on prevention of neonatal mortality and morbidity using a topical antiseptic agent (chlorhexidine, CHX). Specifically we propose to: (1) compare the neonatal mortality among newborn infants randomized to receive either a whole body wipe with a dilute CHX solution (0.25%) or placebo within the first few hours after birth; (2) compare the rates of umbilical cord infections among newborn infants randomized to receive daily cleansing of the umbilical cord for 7 days after birth with either a 4% CHX solution, a soap and water solution, or nothing. The design of this project consists of two nested cluster-randomized, community-based clinical trials. The study population will be all live-born infants who are delivered in Sarlahi District in southern Nepal where our group is conducting a large micronutrient intervention trial with mortality as the outcome among children 1 to 35 months of age. These two trials will be nested underneath the current trial. The area is divided into 425 sectors that will be randomized to one of two immediate post-delivery treatment groups. Infants born to sectors in the treatment group will receive newborn washing with a soft cloth soaked in a 0.25% chlorhexidine solution within the first hours after delivery. Control group infants will be wiped with a similar cloth containing no antimicrobial. All mothers in the study will receive tetanus toxoid during pregnancy and a clean birthing kit. Within each of these two groups, sectors will be further randomized to the three umbilical cord care arms. All groups will receive educational messages regarding hygienic cord care practices for the newborn. All children will be followed intensively for the first 2 weeks and then weekly until 4 weeks of age at which time they will be discharged. The sample size required for the study is 6744 live births per wash group, or 13500 total live births. Assuming a Type I error of 5% and a power of 80%), approximately two years of recruitment will provide adequate numbers to detect a 20% reduction in neonatal mortality. The umbilical cord infection trial will require only one year of recruitment to obtain adequate numbers to detect a 20% in infection rates in the treatment groups.
Showing the most recent 10 out of 38 publications
