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

NCT ID: NCT01177111

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 29260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-01
• Study Completion Date: 2017-06-30

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.

Conditions

Neonatal Mortality; Neonatal Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sunflower seed Oil

Group Type: EXPERIMENTAL

Sunflower seed oil

Intervention Type: OTHER

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

Mustard seed oil

Group Type: ACTIVE_COMPARATOR

Mustard seed oil

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Baby born alive
• Baby born in study area

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nepal Nutrition Intervention Project Sarlahi

OTHER

Sponsor Role: collaborator

Tribhuvan University, Nepal

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luke C Mullany, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Nepal Nutrition Intervention Project

Hariaun, Sarlahi District, Nepal

Countries

Nepal

References

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Reference Type: BACKGROUND

PMID: 19431006 (View on PubMed)

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. doi: 10.3329/jhpn.v27i1.3317.

Reference Type: BACKGROUND

PMID: 19248648 (View on PubMed)

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. doi: 10.1093/tropej/fmh083. Epub 2005 Jan 26.

Reference Type: BACKGROUND

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

PMID: 31870338 (View on PubMed)

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Reference Type: DERIVED

PMID: 30611255 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Other Identifiers

R01HD060712

Identifier Type: NIH

Identifier Source: org_study_id

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