More than 3.1 million neonatal deaths occur annually and account > 40% of under-five mortality. These deaths occur predominately in low-resource settings where many infants are born at home. The long-term objective of our research program is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal and early infant mortality. There is increasing evidence of the role of the neonatal skin and the potential for newborn massage with topical emollients in providing protection from invasive pathogens. This research project focuses on evaluating the impact of newborn massage with sunflower seed oil on neonatal mortality and infections, relative to massage with mustard oil, which is provided almost universally to tens of millions of newborns in South Asia each year. The primary specific aim is to compare the neonatal mortality risk among infants randomized to receive repeated full-body massage during the neonatal period with either sunflower seed oil or mustard seed oil. Secondary aims include a between-group comparison of mortality risk among preterm infants and a comparison of the incidence of probable severe disease (sepsis) between the sunflower and mustard oil groups.
This study is being implemented by the Nepal Nutrition Intervention Project, Sarlahi (NNIPS). The study population will be all live-born infants delivered within our community-based research site in Sarlahi District of southern Nepal. Communities are randomized to either sunflower or mustard oil. Pregnant women within the catchment area are recruited mid-pregnancy, and provided with a set of common basic antenatal interventions. Women are also be provided with either sunflower seed oil or mustard oil, depending on the random allocation of their cluster of residence. The oil, sufficient in quantity to provide full-body massage three times daily for 28 days, is provided by locally resident, village-level workers along with guidelines on the use of the oil and actual conduct of the massage. All women are followed through their pregnancy outcome and 28 days postpartum. After birth of the infant, the local project workers visit each day for the first week of life to continue promoting the massage and measuring compliance. A team of data collectors visits all infants at home on days 1, 3, 7, 10, 14, and 28 to record vital status and basic signs of morbidity. The primary outcome is mortality within 28 days of birth. To detect a 20% reduction in all-cause neonatal mortality with 80% power and Type I error of 5%, the required sample size per group is 14,630 (total = 29,260)