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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177111
First Posted: August 6, 2010
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Nepal Nutrition Intervention Project Sarlahi
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Probable severe disease in newborns will be defined using the current World Health Organization (WHO) Young Infant Study Algorithm and appropriate adaptations


Estimated Enrollment: 29260
Actual Study Start Date: November 1, 2010
Estimated Study Completion Date: April 30, 2017
Primary Completion Date: January 31, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Baby born alive
  • Baby born in study area
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177111


Locations
Nepal
Nepal Nutrition Intervention Project
Hariaun, Sarlahi District, Nepal
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 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2010
First Posted: August 6, 2010
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Mechlorethamine
Neonatal Sepsis
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents