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

April 19, 2018 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Sarlahi District
      • Hariaun, Sarlahi District, Nepal
        • Nepal Nutrition Intervention Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Baby born alive
  • Baby born in study area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause neonatal mortality
Time Frame: 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.
first 28 days after birth
neonatal morbidity
Time Frame: 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
first 28 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Tribhuvan University, Nepal
Nepal Nutrition Intervention Project Sarlahi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2010

Primary Completion (ACTUAL)

January 31, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (ESTIMATE)

August 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD060712 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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