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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Nepal Nutrition Intervention Project Sarlahi
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01177111
First received: August 5, 2010
Last updated: April 5, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Neonatal Mortality
Neonatal Sepsis
Other: Sunflower seed oil
Other: Mustard seed oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • all cause neonatal mortality [ Time Frame: first 28 days after birth ] [ Designated as safety issue: No ]
    A neonatal death is defined as death of a live born baby before completion of reaching 28.0 days old.

  • neonatal morbidity [ Time Frame: first 28 days after birth ] [ Designated as safety issue: No ]
    Probable severe disease in newborns will be defined using the current WHO Young Infant Study Algorithm and appropriate adaptations


Estimated Enrollment: 10000
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunflower seed Oil 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
Active Comparator: Mustard seed oil 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

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mother received project-promoted oil late in pregnancy
  • Baby born alive
  • Baby born in study area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177111

Contacts
Contact: Luke C Mullany, PhD 410-502-2626 lmullany@jhsph.edu

Locations
Nepal
Nepal Nutrition Intervention Project Recruiting
Hariaun, Sarlahi District, Nepal
Contact: Subarna K Khatry, MD       skk@mos.com.np   
Contact: Steven C LeClerq, MPH       sleclerq@mos.com.np   
Principal Investigator: Luke C Mullany, PhD, MHS         
Sub-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         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Nepal Nutrition Intervention Project Sarlahi
Tribhuvan University, Nepal
Investigators
Principal Investigator: Luke C Mullany, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01177111     History of Changes
Other Study ID Numbers: R01HD060712
Study First Received: August 5, 2010
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board
Nepal: Institute of Medicine, Tribhuvan University

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mechlorethamine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014