- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177111
Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal (NOMS)
April 19, 2018 updated by: Johns Hopkins Bloomberg School of Public Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
29260
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sarlahi District
-
Hariaun, Sarlahi District, Nepal
- Nepal Nutrition Intervention Project
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Baby born alive
- Baby born in study area
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
ACTIVE_COMPARATOR: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
first 28 days after birth
|
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
|
first 28 days after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2010
Primary Completion (ACTUAL)
January 31, 2017
Study Completion (ACTUAL)
June 30, 2017
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 5, 2010
First Posted (ESTIMATE)
August 6, 2010
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2018
Last Update Submitted That Met QC Criteria
April 19, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD060712 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Sepsis
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
Yale UniversityWithdrawnA Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64Neonatal Early-onset Sepsis | Neonatal Late-onset SepsisUnited States
-
Franciscus GasthuisErasmus Medical CenterCompletedNeonatal Infection | Neonatal SEPSISNetherlands
-
prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRecruitingEOS | Early-Onset Sepsis, NeonatalNetherlands
-
Sohag UniversityNot yet recruiting
-
Assiut UniversityUnknown
-
Drugs for Neglected DiseasesUniversiteit Antwerpen; PENTA Foundation; St George's, University of LondonCompletedNeonatal SEPSISBangladesh, Uganda, Thailand, South Africa, Italy, Greece, India, Brazil, China, Kenya, Vietnam
-
Assiut UniversityUnknown
-
Assiut UniversityUnknown
-
Hospital Italiano de Buenos AiresCompleted
Clinical Trials on Sunflower seed oil
-
Fudan UniversityCompletedInflammation | Blood Pressure | Oxidative Stress | Pulmonary Function | Vasoconstriction | CoagulationChina
-
Johns Hopkins Bloomberg School of Public HealthCompleted
-
Ramsar international campusCompleted
-
Harvard School of Public Health (HSPH)CompletedCardiovascular Disease
-
Texas Woman's UniversityCompleted
-
Marymount UniversityCompletedHypertension | Elevated Blood PressureUnited States
-
Texas Woman's UniversityCompletedHypertension | DyslipidemiaUnited States
-
Solae, LLCProvident Clinical ResearchCompletedCardiovascular Disease | Sudden Cardiac Death | Sudden Cardiac ArrestUnited States
-
Clinical Nutrition Research Centre, SingaporeCompletedDiabetes Mellitus, Type 2 | Cardiovascular Risk FactorSingapore
-
Wageningen UniversityRadboud University Medical CenterCompletedMild Cognitive ImpairmentNetherlands