NCT01177111: NOMS

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

Completed Phase 3 Last updated 23 April 2018

What this trial tests

Phase 3 trial testing Sunflower seed oil in Neonatal Mortality in 29,260 participants. Completed in 30 June 2017.

Timeline

1 November 2010

Primary endpoint
31 January 2017

30 June 2017

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	29,260
Start date	1 November 2010
Primary completion	31 January 2017
Estimated completion	30 June 2017
Sites	1 location across Nepal

Drugs / interventions tested

• Sunflower seed oil — full drug profile →
• Mustard seed oil

Conditions studied

• Neonatal Mortality — all drugs for Neonatal Mortality →
• Neonatal Sepsis — all drugs for Neonatal Sepsis →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Under 28 Days, any sex, with Neonatal Mortality or Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Cro S, Cornelius V, Lodrup Carlsen KC, et al · · 2021 · cited 43× · PMID 33545739 · DOI 10.1002/14651858.cd013534.pub2
2. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Phillips R, Brown SJ, Cro S, et al · · 2022 · cited 29× · PMID 36373988 · DOI 10.1002/14651858.cd013534.pub3
3. Validation of maternal reports for low birthweight and preterm birth indicators in rural Nepal.
   Chang KT, Mullany LC, Khatry SK, LeClerq SC, et al · · 2018 · cited 27× · PMID 29899981 · DOI 10.7189/jogh.08.010604
4. Accuracy of Home-Based Ultrasonographic Diagnosis of Obstetric Risk Factors by Primary-Level Health Care Workers in Rural Nepal.
   Kozuki N, Mullany LC, Khatry SK, Ghimire RK, et al · · 2016 · cited 23× · PMID 27500343 · DOI 10.1097/aog.0000000000001558
5. Oral health knowledge, behavior, and care seeking among pregnant and recently-delivered women in rural Nepal: a qualitative study.
   Lubon AJ, Erchick DJ, Khatry SK, LeClerq SC, et al · · 2018 · cited 21× · PMID 29859084 · DOI 10.1186/s12903-018-0564-9
6. Coverage of the WHO's four essential elements of newborn care and their association with neonatal survival in southern Nepal.
   Bryce E, Mullany LC, Khatry SK, Tielsch JM, et al · · 2020 · cited 20× · PMID 32938433 · DOI 10.1186/s12884-020-03239-6
7. Oral hygiene, prevalence of gingivitis, and associated risk factors among pregnant women in Sarlahi District, Nepal.
   Erchick DJ, Rai B, Agrawal NK, Khatry SK, et al · · 2019 · cited 20× · PMID 30611255 · DOI 10.1186/s12903-018-0681-5
8. Impact of sunflower seed oil versus mustard seed oil on skin barrier function in newborns: a community-based, cluster-randomized trial.
   Summers A, Visscher MO, Khatry SK, Sherchand JB, et al · · 2019 · cited 19× · PMID 31870338 · DOI 10.1186/s12887-019-1871-2