Clinical trial NCT01177111: Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Official title: Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Mortality
Neonatal Sepsis
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Nepal Nutrition Intervention Project Sarlahi
name: Tribhuvan University, Nepal
First posted: 2010-08-06
Enrollment: 29260
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Baby born alive
* Baby born in study area

Primary outcomes:
measure: all cause neonatal mortality
timeFrame: first 28 days after birth
measure: neonatal morbidity
timeFrame: first 28 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Hariaun
country: Nepal
facility: Nepal Nutrition Intervention Project
state: Sarlahi District
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Luke C Mullany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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