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

Phase 3

Completed

• Conditions: Neonatal Mortality; Neonatal Sepsis
• Interventions: Other: Sunflower seed oil; Other: Mustard seed oil

• Registration Number: NCT01177111
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Study Start: 2010-11-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-06-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29260

Inclusion Criteria

• Baby born alive
• Baby born in study area

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunflower seed Oil	Sunflower seed oil	-
Mustard seed oil	Mustard seed oil	-

Primary Outcome Measures

Name	Time	Method
all cause neonatal mortality	first 28 days after birth	A neonatal death is defined as death of a live born baby before completion of reaching 28.0 days old.
neonatal morbidity	first 28 days after birth	Probable severe disease in newborns will be defined using the current World Health Organization (WHO) Young Infant Study Algorithm and appropriate adaptations

Trial Locations

Locations (1)

Nepal Nutrition Intervention Project; 🇳🇵 Hariaun, Sarlahi District, Nepal