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

Neonatal Sepsis Clinical Trial

— NOMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177111
• Other study ID #: R01HD060712
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2010
• Last updated: April 19, 2018
• Start date: November 1, 2010
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29260
• Est. completion date: June 30, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Baby born alive

• Baby born in study area

Related Conditions & MeSH terms

• Neonatal Mortality
• Neonatal Sepsis

Intervention

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
• 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

Locations

Country	Name	City	State
Nepal	Nepal Nutrition Intervention Project	Hariaun	Sarlahi District

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Nepal Nutrition Intervention Project Sarlahi, Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

References & Publications (3)

Falle TY, Mullany LC, Thatte N, Khatry SK, LeClerq SC, Darmstadt GL, Katz J, Tielsch JM. Potential role of traditional birth attendants in neonatal healthcare in rural southern Nepal. J Health Popul Nutr. 2009 Feb;27(1):53-61. — View Citation

Mullany LC, Darmstadt GL, Khatry SK, Tielsch JM. Traditional massage of newborns in Nepal: implications for trials of improved practice. J Trop Pediatr. 2005 Apr;51(2):82-6. Epub 2005 Jan 26. — View Citation

Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406. — View Citation

Outcome

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