Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial
Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhanc...
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| creator | Kumar, Aarti Mishra, Shambhavi Singh, Shambhavi Ashraf, Sana Kan, Peiyi Ghosh, Amit Kumar Kumar, Alok Krishna, Raghav Stevenson, David K Tian, Lu Elias, Peter M Darmstadt, Gary L Kumar, Vishwajeet |
| description | Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings.
This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the |
| doi_str_mv | 10.1371/journal.pmed.1003680 |
| format | Article |
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This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation.
In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function.
ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.</description><identifier>ISSN: 1549-1676</identifier><identifier>ISSN: 1549-1277</identifier><identifier>EISSN: 1549-1676</identifier><identifier>DOI: 10.1371/journal.pmed.1003680</identifier><identifier>PMID: 34582448</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Administration, Topical ; Adult ; Adverse events ; Biology and Life Sciences ; Birth weight ; Care and treatment ; Clinical trials ; Cluster Analysis ; Counseling ; Dermatologic agents ; Dermatology ; Emollients - therapeutic use ; Empowerment ; Female ; Formulae, receipts, prescriptions ; Gestational age ; Helianthus ; Households ; Humans ; India - epidemiology ; Infant ; Infant Mortality ; Infant, Newborn ; Infant, Premature ; Infants ; Infants (Premature) ; Low-birth-weight ; Male ; Massage ; Medicine and Health Sciences ; Mortality ; Mustard Plant ; Neonates ; Newborn babies ; NMR ; Nuclear magnetic resonance ; Oilseeds ; Pathogens ; Patient outcomes ; Pediatric research ; People and Places ; Plant Oils - therapeutic use ; Pregnancy ; Sepsis ; Skin ; Skin care products ; Skin Cream - therapeutic use ; Socioeconomic Factors ; Statistical analysis ; Sunflower Oil - administration & dosage ; Sunflower Oil - therapeutic use ; Sunflower seed oil ; Surveillance ; Testing ; Womens health ; Workers</subject><ispartof>PLoS medicine, 2021-09, Vol.18 (9), p.e1003680-e1003680</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Kumar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Kumar et al 2021 Kumar et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c764t-2f11337877d621d2d9369d4b61b58e852bf475c0a842391e7e6afc66c1e77c9d3</citedby><cites>FETCH-LOGICAL-c764t-2f11337877d621d2d9369d4b61b58e852bf475c0a842391e7e6afc66c1e77c9d3</cites><orcidid>0000-0002-6942-6718 ; 0000-0002-5279-3685 ; 0000-0002-7057-067X ; 0000-0003-1084-7152 ; 0000-0003-4331-3747 ; 0000-0002-5079-756X ; 0000-0003-3685-537X ; 0000-0002-7522-5824</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478176/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478176/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2100,2926,23865,27923,27924,53790,53792,79371,79372</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34582448$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Bassat, Quique</contributor><creatorcontrib>Kumar, Aarti</creatorcontrib><creatorcontrib>Mishra, Shambhavi</creatorcontrib><creatorcontrib>Singh, Shambhavi</creatorcontrib><creatorcontrib>Ashraf, Sana</creatorcontrib><creatorcontrib>Kan, Peiyi</creatorcontrib><creatorcontrib>Ghosh, Amit Kumar</creatorcontrib><creatorcontrib>Kumar, Alok</creatorcontrib><creatorcontrib>Krishna, Raghav</creatorcontrib><creatorcontrib>Stevenson, David K</creatorcontrib><creatorcontrib>Tian, Lu</creatorcontrib><creatorcontrib>Elias, Peter M</creatorcontrib><creatorcontrib>Darmstadt, Gary L</creatorcontrib><creatorcontrib>Kumar, Vishwajeet</creatorcontrib><creatorcontrib>Shivgarh Emollient Research Group</creatorcontrib><creatorcontrib>for the Shivgarh Emollient Research Group</creatorcontrib><title>Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial</title><title>PLoS medicine</title><addtitle>PLoS Med</addtitle><description>Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings.
This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation.
In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function.
ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.</description><subject>Administration, Topical</subject><subject>Adult</subject><subject>Adverse events</subject><subject>Biology and Life Sciences</subject><subject>Birth weight</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Cluster Analysis</subject><subject>Counseling</subject><subject>Dermatologic agents</subject><subject>Dermatology</subject><subject>Emollients - therapeutic use</subject><subject>Empowerment</subject><subject>Female</subject><subject>Formulae, receipts, prescriptions</subject><subject>Gestational age</subject><subject>Helianthus</subject><subject>Households</subject><subject>Humans</subject><subject>India - epidemiology</subject><subject>Infant</subject><subject>Infant Mortality</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infants</subject><subject>Infants (Premature)</subject><subject>Low-birth-weight</subject><subject>Male</subject><subject>Massage</subject><subject>Medicine and Health Sciences</subject><subject>Mortality</subject><subject>Mustard Plant</subject><subject>Neonates</subject><subject>Newborn babies</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Oilseeds</subject><subject>Pathogens</subject><subject>Patient outcomes</subject><subject>Pediatric research</subject><subject>People and Places</subject><subject>Plant Oils - therapeutic use</subject><subject>Pregnancy</subject><subject>Sepsis</subject><subject>Skin</subject><subject>Skin care products</subject><subject>Skin Cream - therapeutic use</subject><subject>Socioeconomic Factors</subject><subject>Statistical analysis</subject><subject>Sunflower Oil - administration & dosage</subject><subject>Sunflower Oil - therapeutic use</subject><subject>Sunflower seed oil</subject><subject>Surveillance</subject><subject>Testing</subject><subject>Womens health</subject><subject>Workers</subject><issn>1549-1676</issn><issn>1549-1277</issn><issn>1549-1676</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqVk1FrFDEQxxdRbK1-A9FAQRS6Z7LJbXZ9EEqpelCsqPU1ZJPZu5RscibZ1vp9_J7m7LX05B6Ufdhk8pv_TGYyRfGU4AmhnLw-92Nw0k6WA-gJwZjWDb5X7JIpa0tS8_r-nfVO8SjGc4yrFrf4YbFD2bSpGGt2i1_HfQ8qId-jOLre-ksIKAJo5I1FMHhrDbiE0gKCXF4h75CDy84Hh4zrZT6JY7gwF9LmPTpLSQb0KUgNcXGAZk4b-QYdIuWHYXQmXZWdjKAPkLJjTDlSkE77wfxc2fwSXGllBzbzLoUcOqeRgpH2cfGglzbCk_V_rzh7d_z16EN5cvp-dnR4Uipes1RWPSGU8oZzXVdEV7qldatZV5Nu2kAzrbqe8anCsmEVbQlwqGWv6lrlJVetpnvF82vdpfVRrCscRZWrNW1aSqtMzK4J7eW5WAYzyHAlvDTij8GHuZAhGWVBcAa8UZzhrsVMM2ihZbiifU6myul1WevtOtrY5SaqXOcg7Ybo5okzCzH3F6JhvCG8zgIv1wLBfx8hJjGYqMBa6cCPq7w55xSzmmR0_y90--3W1FzmC-QG-xxXrUTFYc1520w5pZkqt1BzcPmJWO-gN9m8wU-28PnTMBi11eHVhsPqOcCPNJdjjGL25fN_sB__nT39tsm-uMMuQNq0iN6OyXgXN0F2DargYwzQ3zaQYLGa1JtKi9WkivWkZrdnd5t_63QzmvQ37gU5LQ</recordid><startdate>20210928</startdate><enddate>20210928</enddate><creator>Kumar, Aarti</creator><creator>Mishra, Shambhavi</creator><creator>Singh, Shambhavi</creator><creator>Ashraf, Sana</creator><creator>Kan, Peiyi</creator><creator>Ghosh, Amit Kumar</creator><creator>Kumar, Alok</creator><creator>Krishna, Raghav</creator><creator>Stevenson, David K</creator><creator>Tian, Lu</creator><creator>Elias, Peter M</creator><creator>Darmstadt, Gary L</creator><creator>Kumar, Vishwajeet</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISN</scope><scope>ISR</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><scope>CZK</scope><orcidid>https://orcid.org/0000-0002-6942-6718</orcidid><orcidid>https://orcid.org/0000-0002-5279-3685</orcidid><orcidid>https://orcid.org/0000-0002-7057-067X</orcidid><orcidid>https://orcid.org/0000-0003-1084-7152</orcidid><orcidid>https://orcid.org/0000-0003-4331-3747</orcidid><orcidid>https://orcid.org/0000-0002-5079-756X</orcidid><orcidid>https://orcid.org/0000-0003-3685-537X</orcidid><orcidid>https://orcid.org/0000-0002-7522-5824</orcidid></search><sort><creationdate>20210928</creationdate><title>Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial</title><author>Kumar, Aarti ; Mishra, Shambhavi ; Singh, Shambhavi ; Ashraf, Sana ; Kan, Peiyi ; Ghosh, Amit Kumar ; Kumar, Alok ; Krishna, Raghav ; Stevenson, David K ; Tian, Lu ; Elias, Peter M ; Darmstadt, Gary L ; Kumar, Vishwajeet</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c764t-2f11337877d621d2d9369d4b61b58e852bf475c0a842391e7e6afc66c1e77c9d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Administration, Topical</topic><topic>Adult</topic><topic>Adverse events</topic><topic>Biology and Life Sciences</topic><topic>Birth weight</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Cluster Analysis</topic><topic>Counseling</topic><topic>Dermatologic agents</topic><topic>Dermatology</topic><topic>Emollients - therapeutic use</topic><topic>Empowerment</topic><topic>Female</topic><topic>Formulae, receipts, prescriptions</topic><topic>Gestational age</topic><topic>Helianthus</topic><topic>Households</topic><topic>Humans</topic><topic>India - epidemiology</topic><topic>Infant</topic><topic>Infant Mortality</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infants</topic><topic>Infants (Premature)</topic><topic>Low-birth-weight</topic><topic>Male</topic><topic>Massage</topic><topic>Medicine and Health Sciences</topic><topic>Mortality</topic><topic>Mustard Plant</topic><topic>Neonates</topic><topic>Newborn babies</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Oilseeds</topic><topic>Pathogens</topic><topic>Patient outcomes</topic><topic>Pediatric research</topic><topic>People and Places</topic><topic>Plant Oils - therapeutic use</topic><topic>Pregnancy</topic><topic>Sepsis</topic><topic>Skin</topic><topic>Skin care products</topic><topic>Skin Cream - therapeutic use</topic><topic>Socioeconomic Factors</topic><topic>Statistical analysis</topic><topic>Sunflower Oil - administration & dosage</topic><topic>Sunflower Oil - therapeutic use</topic><topic>Sunflower seed oil</topic><topic>Surveillance</topic><topic>Testing</topic><topic>Womens health</topic><topic>Workers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kumar, Aarti</creatorcontrib><creatorcontrib>Mishra, Shambhavi</creatorcontrib><creatorcontrib>Singh, Shambhavi</creatorcontrib><creatorcontrib>Ashraf, Sana</creatorcontrib><creatorcontrib>Kan, Peiyi</creatorcontrib><creatorcontrib>Ghosh, Amit Kumar</creatorcontrib><creatorcontrib>Kumar, Alok</creatorcontrib><creatorcontrib>Krishna, Raghav</creatorcontrib><creatorcontrib>Stevenson, David K</creatorcontrib><creatorcontrib>Tian, Lu</creatorcontrib><creatorcontrib>Elias, Peter M</creatorcontrib><creatorcontrib>Darmstadt, Gary L</creatorcontrib><creatorcontrib>Kumar, Vishwajeet</creatorcontrib><creatorcontrib>Shivgarh Emollient Research Group</creatorcontrib><creatorcontrib>for the Shivgarh Emollient Research Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Canada</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><collection>PLoS Medicine</collection><jtitle>PLoS medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kumar, Aarti</au><au>Mishra, Shambhavi</au><au>Singh, Shambhavi</au><au>Ashraf, Sana</au><au>Kan, Peiyi</au><au>Ghosh, Amit Kumar</au><au>Kumar, Alok</au><au>Krishna, Raghav</au><au>Stevenson, David K</au><au>Tian, Lu</au><au>Elias, Peter M</au><au>Darmstadt, Gary L</au><au>Kumar, Vishwajeet</au><au>Bassat, Quique</au><aucorp>Shivgarh Emollient Research Group</aucorp><aucorp>for the Shivgarh Emollient Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial</atitle><jtitle>PLoS medicine</jtitle><addtitle>PLoS Med</addtitle><date>2021-09-28</date><risdate>2021</risdate><volume>18</volume><issue>9</issue><spage>e1003680</spage><epage>e1003680</epage><pages>e1003680-e1003680</pages><issn>1549-1676</issn><issn>1549-1277</issn><eissn>1549-1676</eissn><abstract>Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings.
This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation.
In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function.
ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>34582448</pmid><doi>10.1371/journal.pmed.1003680</doi><orcidid>https://orcid.org/0000-0002-6942-6718</orcidid><orcidid>https://orcid.org/0000-0002-5279-3685</orcidid><orcidid>https://orcid.org/0000-0002-7057-067X</orcidid><orcidid>https://orcid.org/0000-0003-1084-7152</orcidid><orcidid>https://orcid.org/0000-0003-4331-3747</orcidid><orcidid>https://orcid.org/0000-0002-5079-756X</orcidid><orcidid>https://orcid.org/0000-0003-3685-537X</orcidid><orcidid>https://orcid.org/0000-0002-7522-5824</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1549-1676 |
| ispartof | PLoS medicine, 2021-09, Vol.18 (9), p.e1003680-e1003680 |
| issn | 1549-1676 1549-1277 1549-1676 |
| language | eng |
| recordid | cdi_plos_journals_2582589332 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central |
| subjects | Administration, Topical Adult Adverse events Biology and Life Sciences Birth weight Care and treatment Clinical trials Cluster Analysis Counseling Dermatologic agents Dermatology Emollients - therapeutic use Empowerment Female Formulae, receipts, prescriptions Gestational age Helianthus Households Humans India - epidemiology Infant Infant Mortality Infant, Newborn Infant, Premature Infants Infants (Premature) Low-birth-weight Male Massage Medicine and Health Sciences Mortality Mustard Plant Neonates Newborn babies NMR Nuclear magnetic resonance Oilseeds Pathogens Patient outcomes Pediatric research People and Places Plant Oils - therapeutic use Pregnancy Sepsis Skin Skin care products Skin Cream - therapeutic use Socioeconomic Factors Statistical analysis Sunflower Oil - administration & dosage Sunflower Oil - therapeutic use Sunflower seed oil Surveillance Testing Womens health Workers |
| title | Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial |
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