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 mortalityneonatal 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
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