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

NCT01177111 | Completed Phase 3 DMC

• 1 other identifier: R01HD060712
• Study Type: interventional
• Target: 29,260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• all cause neonatal mortality

  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

  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

Study Arms (2)

Sunflower seed Oil

EXPERIMENTAL

Other: Sunflower seed oil

Mustard seed oil

ACTIVE COMPARATOR

Other: Mustard seed oil

Interventions

Sunflower seed oil 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

Sunflower seed Oil

Mustard seed oil 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

Mustard seed oil

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Baby born alive
• Baby born in study area

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Nepal Nutrition Intervention Project Sarlahi: collaborator
• Tribhuvan University, Nepal: collaborator

Study Sites (1)

Nepal Nutrition Intervention Project

Hariaun, Sarlahi District, Nepal

Location

Related Publications (16)

• Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406.

  PMID: 19431006 BACKGROUND

• 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.

  PMID: 19248648 BACKGROUND

• 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.

  PMID: 15677372 BACKGROUND

• Yue Y, Hazel EA, Subedi S, Zeger S, Mohan D, Mullany LC, Tielsch JM, Khatry SK, LeClerq SC, Katz J. Factors Predicting Completion of Four or More Antenatal Care Visits in Sarlahi District, Nepal. Res Sq [Preprint]. 2024 May 29:rs.3.rs-4467441. doi: 10.21203/rs.3.rs-4467441/v1.

  PMID: 38853894 DERIVED

• Katz J, Khatry SK, Shrestha L, Summers A, Visscher MO, Sherchand JB, Tielsch JM, Subedi S, LeClerq SC, Mullany LC. Impact of topical applications of sunflower seed oil on neonatal mortality and morbidity in southern Nepal: a community-based, cluster-randomised trial. BMJ Glob Health. 2024 Feb 29;9(2):e013691. doi: 10.1136/bmjgh-2023-013691.

  PMID: 38423547 DERIVED

• Yan T, Mullany LC, Subedi S, Hazel EA, Khatry SK, Mohan D, Zeger S, Tielsch JM, LeClerq SC, Katz J. Risk factors for neonatal mortality: an observational cohort study in Sarlahi district of rural southern Nepal. BMJ Open. 2023 Sep 14;13(9):e066931. doi: 10.1136/bmjopen-2022-066931.

  PMID: 37709319 DERIVED

• Subedi S, Hazel EA, Mohan D, Zeger S, Mullany LC, Tielsch JM, Khatry SK, LeClerq SC, Black RE, Katz J. Prevalence and predictors of spontaneous preterm births in Nepal: findings from a prospective, population-based pregnancy cohort in rural Nepal-a secondary data analysis. BMJ Open. 2022 Dec 1;12(12):e066934. doi: 10.1136/bmjopen-2022-066934.

  PMID: 36456014 DERIVED

• Hazel EA, Mohan D, Zeger S, Mullany LC, Tielsch JM, Khatry SK, Subedi S, LeClerq SC, Black RE, Katz J. Demographic, socio-economic, obstetric, and behavioral factors associated with small-and large-for-gestational-age from a prospective, population-based pregnancy cohort in rural Nepal: a secondary data analysis. BMC Pregnancy Childbirth. 2022 Aug 19;22(1):652. doi: 10.1186/s12884-022-04974-8.

  PMID: 35986258 DERIVED

• Subedi S, Katz J, Erchick DJ, Verhulst A, Khatry SK, Mullany LC, Tielsch JM, LeClerq SC, Christian P, West KP, Guillot M. Does higher early neonatal mortality in boys reverse over the neonatal period? A pooled analysis from three trials of Nepal. BMJ Open. 2022 May 19;12(5):e056112. doi: 10.1136/bmjopen-2021-056112.

  PMID: 35589346 DERIVED

• Erchick DJ, Khatry SK, Agrawal NK, Katz J, LeClerq SC, Rai B, Reynolds MA, Mullany LC. Risk of preterm birth associated with maternal gingival inflammation and oral hygiene behaviours in rural Nepal: a community-based, prospective cohort study. BMJ Open. 2020 Aug 20;10(8):e036515. doi: 10.1136/bmjopen-2019-036515.

  PMID: 32819989 DERIVED

• Erchick DJ, Agrawal NK, Khatry SK, Katz J, LeClerq SC, Rai B, Reynolds MA, Mullany LC. Feasibility of training community health workers to conduct periodontal examinations: a validation study in rural Nepal. BMC Health Serv Res. 2020 May 11;20(1):412. doi: 10.1186/s12913-020-05276-5.

  PMID: 32393349 DERIVED

• Summers A, Visscher MO, Khatry SK, Sherchand JB, LeClerq SC, Katz J, Tielsch JM, Mullany LC. Impact of sunflower seed oil versus mustard seed oil on skin barrier function in newborns: a community-based, cluster-randomized trial. BMC Pediatr. 2019 Dec 23;19(1):512. doi: 10.1186/s12887-019-1871-2.

  PMID: 31870338 DERIVED

• Erchick DJ, Rai B, Agrawal NK, Khatry SK, Katz J, LeClerq SC, Reynolds MA, Mullany LC. Oral hygiene, prevalence of gingivitis, and associated risk factors among pregnant women in Sarlahi District, Nepal. BMC Oral Health. 2019 Jan 5;19(1):2. doi: 10.1186/s12903-018-0681-5.

  PMID: 30611255 DERIVED

• Lubon AJ, Erchick DJ, Khatry SK, LeClerq SC, Agrawal NK, Reynolds MA, Katz J, Mullany LC. Oral health knowledge, behavior, and care seeking among pregnant and recently-delivered women in rural Nepal: a qualitative study. BMC Oral Health. 2018 Jun 1;18(1):97. doi: 10.1186/s12903-018-0564-9.

  PMID: 29859084 DERIVED

• Lama TP, Khatry SK, Katz J, LeClerq SC, Mullany LC. Illness recognition, decision-making, and care-seeking for maternal and newborn complications: a qualitative study in Sarlahi District, Nepal. J Health Popul Nutr. 2017 Dec 21;36(Suppl 1):45. doi: 10.1186/s41043-017-0123-z.

  PMID: 29297386 DERIVED

• Kozuki N, Katz J, Khatry SK, Tielsch JM, LeClerq SC, Mullany LC. Risk and burden of adverse intrapartum-related outcomes associated with non-cephalic and multiple birth in rural Nepal: a prospective cohort study. BMJ Open. 2017 Apr 20;7(4):e013099. doi: 10.1136/bmjopen-2016-013099.

  PMID: 28428183 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Luke C Mullany, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: November 1, 2010
• Primary Completion: January 31, 2017
• Study Completion: June 30, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

NE (1)