Neonatal MortalityPhase 3NOMSNCT01177111
Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
A Phase 3 study testing Sunflower seed oil and Mustard seed oil in people with Neonatal Mortality and Neonatal Sepsis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Mortality, Neonatal Sepsis
- What is being tested?
- Sunflower seed oil and Mustard seed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,260 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2010to 30 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Baby born alive
- Baby born in study area
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Sunflower seed oil, Mustard seed oil
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower seed oilOther
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 oilOther
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
| Study group | Role | What they receive |
|---|---|---|
| Sunflower seed Oil | Experimental | Not described Receives: Other: Sunflower seed oil |
| Mustard seed oil | Active comparator | Not described Receives: Other: Mustard seed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause neonatal mortality
A neonatal death is defined as death of a live born baby before completion of reaching 28.0 days old.
Measured: 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
Measured: first 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study start1 Nov 2010
- Primary completion31 Jan 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Neonatal MortalityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Nepal Nutrition Intervention Project Sarlahi, Tribhuvan University, Nepal
- Responsible party
- Sponsor
- Investigators
- Luke C Mullany, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177111
- Sponsor's protocol ID
- R01HD060712
- Acronym
- NOMS
- Status last verified
- Apr 2018
- First submitted
- 5 Aug 2010
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19431006Falle 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.
PubMed 19248648Mullany 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.
PubMed 15677372Yue Y, Hazel EA, Subedi S, Zeger S, Mohan D, Mullany LC, Tielsch JM, Khatry S, LeClerq SC, Katz J. Observational analysis of factors associated with completion of four or more antenatal care visits in Sarlahi district, Nepal. BMJ Open. 2026 Mar 10;16(3):e098478. doi: 10.1136/bmjopen-2024-098478.
PubMed 41806992Chen CCG, Kao ML, Lulseged BA, Khatry SK, Singh M, LeClerq SC, Katz J, Tielsch JM, Mullany LC. Risk Factors of Pelvic Floor Disorders Among Women in Rural Nepal: A Case-Control Study. Int Urogynecol J. 2024 Aug;35(8):1643-1652. doi: 10.1007/s00192-024-05843-y. Epub 2024 Jul 3.
PubMed 38958728Yue 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.
PubMed 38853894Katz 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.
PubMed 38423547Yan 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.
PubMed 37709319Subedi 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.
PubMed 36456014Hazel 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.
PubMed 35986258Subedi 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.
PubMed 35589346Erchick 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.
PubMed 32819989Erchick 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.
PubMed 32393349Summers 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.
PubMed 31870338Erchick 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.
PubMed 30611255
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
- ClinicalTrials.gov ID
- NCT01177111
- Acronym / sponsor ID
- NOMS / R01HD060712
- Conditions
- Neonatal Mortality, Neonatal Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29,260 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Nepal Nutrition Intervention Project Sarlahi, Tribhuvan University, Nepal
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunflower seed Oil | Experimental | Other: Sunflower seed oil |
| Mustard seed oil | Active comparator | Other: Mustard seed oil |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Baby born alive
- Baby born in study area
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunflower seed oilLocally 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 | Other | Sunflower seed Oil |
| Mustard seed oilLocally 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 | Other | Mustard seed oil |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Background: PubMed 19431006Thatte 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.
- Background: PubMed 19248648Falle 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.
- Background: PubMed 15677372Mullany 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.
- Derived from this study: PubMed 41806992Yue Y, Hazel EA, Subedi S, Zeger S, Mohan D, Mullany LC, Tielsch JM, Khatry S, LeClerq SC, Katz J. Observational analysis of factors associated with completion of four or more antenatal care visits in Sarlahi district, Nepal. BMJ Open. 2026 Mar 10;16(3):e098478. doi: 10.1136/bmjopen-2024-098478.
- Derived from this study: PubMed 38958728Chen CCG, Kao ML, Lulseged BA, Khatry SK, Singh M, LeClerq SC, Katz J, Tielsch JM, Mullany LC. Risk Factors of Pelvic Floor Disorders Among Women in Rural Nepal: A Case-Control Study. Int Urogynecol J. 2024 Aug;35(8):1643-1652. doi: 10.1007/s00192-024-05843-y. Epub 2024 Jul 3.
- Derived from this study: PubMed 38853894Yue 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.
- Derived from this study: PubMed 38423547Katz 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.
- Derived from this study: PubMed 37709319Yan 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.
- Derived from this study: PubMed 36456014Subedi 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.
- Derived from this study: PubMed 35986258Hazel 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.
- Derived from this study: PubMed 35589346Subedi 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.
- Derived from this study: PubMed 32819989Erchick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke C Mullany, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sunflower seed oil and Mustard seed oil in people with Neonatal Mortality and Neonatal Sepsis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause neonatal mortality (time frame: first 28 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177111, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.