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

Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Mortality; Neonatal Sepsis

Intervention: Sunflower seed oil (Other); Mustard seed oil (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Luke C Mullany, PhD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health

Overall contact:
Luke C Mullany, PhD, Phone: 410-575-4044, Email: lmullany@jhu.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

all cause neonatal mortality

neonatal morbidity

Eligibility

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Mother received project-promoted oil late in pregnancy

- Baby born alive

- Baby born in study area

Locations and Contacts

Luke C Mullany, PhD, Phone: 410-575-4044, Email: lmullany@jhu.edu

Nepal Nutrition Intervention Project, Hariaun, Sarlahi District, Nepal; Recruiting
Subarna K Khatry, MD, Email: skk@mos.com.np
Steven C LeClerq, MPH, Email: sleclerq@mos.com.np
Luke C Mullany, PhD, MHS, Principal Investigator
Subarna K Khatry, MD, Sub-Investigator
Steven C LeClerq, MPH, Sub-Investigator
Joanne Katz, ScD, Sub-Investigator
Laxman Shrestha, MD, Sub-Investigator
Ramesh K Adhikari, MD, Sub-Investigator
James M Tielsch, PhD, Sub-Investigator
Additional Information

Related publications:

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.

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.

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.

Starting date: November 2010
Last updated: April 15, 2015

Page last updated: August 23, 2015

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