NCT01177111

Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29,260 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

Summary

Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings where neonatal mortality rates are high. Infections are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The investigators long term goal is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal mortality risk due to these infections. The investigators team has conducted research in this area for the past 10 years, with specific focus on newborn vitamin A dosing and topical chlorhexidine antisepsis interventions. Previous community-based research by the investigators group of investigators and others demonstrated that newborn vitamin A dosing can reduce early infant mortality by approximately 20%, and that topical applications of chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk by 24%. Evidence is growing that neonatal skin plays an important role in protecting the newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is incomplete in newborn infants, especially those that are pre-term or of low birth weight. Full-body massage of newborns with mustard oil, practiced almost universally (\~95%) in communities of south Asia, may further compromise skin barrier function through decreased structural integrity leading to increased trans-epidermal water loss and increased risk of percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen after massage of neonatal skin with alternative topical emollients, including sunflower seed oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin barrier function, improve skin condition, and reduce the risk of both nosocomial infections and neonatal mortality among hospitalized newborns in low-resource settings. The specific hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical applications during full body massage of newborns in the community will reduce neonatal mortality and morbidity by improving overall skin barrier function and reducing exposure to invasive pathogens.

Conditions

• Neonatal Mortality
• Neonatal Sepsis

Interventions

Type	Name	Description
OTHER	Sunflower seed oil	Locally manufactured refined sunflower seed oil will be provided to pregnant women late in pregnancy and community workers will promote its daily use during massage of newborns during the first month of life
OTHER	Mustard seed oil	Locally manufactured mustard seed oil will be provided to pregnant women late in pregnancy and community workers will promote its daily use during massage of newborns during the first month of life

Timeline

• Start date: 2010-11-01
• Primary completion: 2017-01-31
• Completion: 2017-06-30
• First posted: 2010-08-06
• Last updated: 2018-04-23

Locations

1 site across 1 country: Nepal