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Trial record 10 of 203 for:    MIRASOL

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

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ClinicalTrials.gov Identifier: NCT01177111
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Nepal Nutrition Intervention Project Sarlahi
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 6, 2010
Last Update Posted Date April 23, 2018
Actual Study Start Date  ICMJE November 1, 2010
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
  • 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 ]
    Probably severe disease in newborns will be defined using the current WHO Young Infant Study Algorithm and appropriate adaptations
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Official Title  ICMJE Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Neonatal Mortality
  • Neonatal Sepsis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Sunflower seed Oil
    Intervention: Other: Sunflower seed oil
  • Active Comparator: Mustard seed oil
    Intervention: Other: Mustard seed oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 15, 2015)
29260
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2010)
10000
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Baby born alive
  • Baby born in study area
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01177111
Other Study ID Numbers  ICMJE R01HD060712( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • Nepal Nutrition Intervention Project Sarlahi
  • Tribhuvan University, Nepal
Investigators  ICMJE
Principal Investigator: Luke C Mullany, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP