[논문]Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial

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

doi:10.1371/journal.pmed.1003680

Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial 원문보기

PLoS medicine, v.18 no.9, 2021년, pp.e1003680 -

Kumar, Aarti (Community Empowerment Lab, Lucknow, Uttar Pradesh, India) , Mishra, Shambhavi (Community Empowerment Lab, Lucknow, Uttar Pradesh, India) , Singh, Shambhavi (Community Empowerment Lab, Lucknow, Uttar Pradesh, India) , Ashraf, Sana (Community Empowerment Lab, Lucknow, Uttar Pradesh, India) , Kan, Peiyi (Prematurity Research Center, Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, United States of America) , Ghosh, Amit Kumar (Government of India, India) , Kumar, Alok (Government of Uttar Pradesh, India) , Krishna, Raghav (Community Empowerment Lab, Lucknow, Uttar Pradesh, India) , Stevenson, David K. (Prematurity Research Center, Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, United States of America) , Tian, Lu (Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California, United States of America) , Elias, Peter M. (Department of Dermatology, University of California, San Francisco, California, United States of America) , Darmstadt, Gary L. (Prematurity Res) , Kumar, Vishwajeet

Abstract ▼ AI-Helper

BackgroundHospitalized 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.Methods and findingsThis 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.ConclusionsIn 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.Trial registrationISRCTN Registry ISRCTN38965585 and Clinical Trials Registry—India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.In a cluster randomized trial, Aarti Kumar and colleagues study the effectiveness of a topical sunflower seed oil therapy in reducing neonatal mortality in Uttar Pradesh, India.Author summary

참고문헌 (42)

1 Darmstadt GL , Badrawi N , Law PA , Ahmed S , Bashir M , Iskander I , et al . Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial . Pediatr Infect Dis J . 2004 ; 23 ( 8 ): 719 – 25 . doi: 10.1097/01.inf.0000133047.50836.6f 15295221

상세보기
2 Darmstadt GL , Saha SK , Ahmed AS , Chowdhury MA , Law PA , Ahmed S , et al . Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial . Lancet . 2005 ; 365 ( 9464 ): 1039 – 45 . doi: 10.1016/S0140-6736(05)71140-5 15781099

상세보기
3 Darmstadt GL , Saha SK , Ahmed AS , Ahmed S , Chowdhury MA , Law PA , et al . Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial . Pediatrics . 2008 ; 121 ( 3 ): 522 – 9 . doi: 10.1542/peds.2007-0213 18310201

상세보기
4 Salam RA , Darmstadt GL , Bhutta ZA . Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial . Arch Dis Child Fetal Neonatal Ed . 2015 ; 100 ( 3 ): F210 – 5 . doi: 10.1136/archdischild-2014-307157 25637007

상세보기
5 Salam RA , Das JK , Darmstadt GL , Bhutta ZA . Emollient therapy for preterm newborn infants–evidence from the developing world . BMC Public Health . 2013 ; 13 ( Suppl 3 ): S31 . 24564550
6 Visscher MO , Adam R , Brink S , Odio M . Newborn infant skin: Physiology, development, and care . Clin Dermatol. 2015 ; 33 ( 3 ): 271 – 80 . doi: 10.1016/j.clindermatol.2014.12.003 25889127

상세보기
7 Williams M. Skin of the premature infant . In: Eichenfield L , Frieden I , Esterly N , eds. Textbook of neonatal dermatology . Philadelphia : WB Saunders Co ; 2001 . p. 46 – 61 .
8 Kalia Y , Nonato L , Lund C , Guy R . Development of skin barrier function in premature infants . J Invest Dermatol . 1998 ; 111 : 320 – 6 . doi: 10.1046/j.1523-1747.1998.00289.x 9699737

상세보기
9 Williams M , Hanley K , Elias P , Feingold K . Ontogeny of the epidermal permeability barrier . J Invest Dermatol Symp Proc . 1998 ; 3 : 75 – 9 . doi: 10.1038/jidsymp.1998.18 9734818

상세보기
10 Hammarlund K , Sedin G . Transepidermal water loss in newborn infants, III: relation to gestational age . Acta Paediatr Scand . 1979 ; 68 : 795 – 801 . doi: 10.1111/j.1651-2227.1979.tb08214.x 539401

상세보기
11 Man M-Q , Feingold KR , Thornfeldt CR , Elias PM . Optimization of physiological lipid mixtures for barrier repair . J Invest Dermatol . 1996 ; 106 ( 5 ): 1096 – 101 . doi: 10.1111/1523-1747.ep12340135 8618046

상세보기
12 Darmstadt GL , Man M-Q , Chi E , Saha SK , Ziboh V , Black RE , et al . Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries . Acta Paediatr . 2002 ; 91 ( 5 ): 546 – 54 . doi: 10.1080/080352502753711678 12113324
13 Man M-Q , Sun R , Man G , Lee D , Hill Z , Elias PM . Commonly employed African neonatal skin care products compromise epidermal function in mice . Pediatr Dermatol . 2016 ; 33 ( 5 ): 493 – 500 . doi: 10.1111/pde.12901 27396436

상세보기
14 Kumar V , Kumar A , Ghosh AK , Samphel R , Yadav R , Yeung D , et al . Enculturating science: Community-centric design of behavior change interactions for accelerating health impact . Semin Perinatol. 2015 ; 39 ( 5 ). doi: 10.1053/j.semperi.2015.06.010 26215599

상세보기
15 Kumar V , Mohanty S , Kumar A , Misra RP , Santosham M , Awasthi S , et al . Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial . Lancet . 2008 ; 372 ( 9644 ): 1151 – 62 . doi: 10.1016/S0140-6736(08)61483-X 18926277

상세보기
16 Kumar V , Kumar A . Impact of topical application of cold-pressed sunflower seed oil with improved massage practices on neonatal mortality: a cluster randomized controlled trial in rural North India, May 14, 2014 . Harvard Dataverse, V1 . doi: 10.7910/DVN/TGNC9H
17 Hayes R , Moulton L . Cluster randomised trials . Vol. 65 . Boca Raton : CRC ; 2009 .
18 The Alliance for Maternal and Newborn Health Improvement (AMANHI) mortality study group . Population-based rates, timing, and causes of maternal deaths, stillbirths, and neonatal deaths in south Asia and sub-Saharan Africa: a multi-country prospective cohort study . Lancet Glob Health . 2018 ; 6 : e1297 – 308 . doi: 10.1016/S2214-109X(18)30385-1 30361107

상세보기
19 Olsen IE , Groveman SA , Lawson ML , Clark RH , Zemel BS . New intrauterine growth curves based on United States data . Pediatrics . 2010 Feb ; 125 ( 2 ): e214 – 24 . doi: 10.1542/peds.2009-0913 20100760

상세보기
20 Summers A , Visscher MO , Khatry SK , Sherchand JB , LeClerq SC , Katz J , et al . Impact of sunflower seed oil versus mustard seed oil on skin barrier function in newborns: a community-based, cluster-randomized trial . BMC Pediatr . 2019 ; 19 ( 1 ): 512 . doi: 10.1186/s12887-019-1871-2 31870338

상세보기
21 Summers A , Visscher MO , Khatry SK , Sherchand JB , LeClerq SC , Katz J , et al . Indicators of skin barrier integrity among newborns massaged with mustard oil in rural Nepal. J Perinatol . 2018 ; 38 ( 1 ): 64 – 70 . doi: 10.1038/jp.2017.158 29120456

상세보기
22 Ahmed AS , Saha SK , Chowdhury MA , Law PA , Black RE , Santosham M , et al . Acceptability of massage with skin barrier-enhancing emollients in young neonates in Bangladesh . J Health Popul Nutr . 2007 ; 25 ( 2 ): 236 – 40 . 17985826

상세보기
23 Darmstadt GL , Saha SK , Ahmed AS , Choi Y , Chowdhury MA , Islam M , et al . Effect of topical emollient treatment of preterm neonates in Bangladesh on invasion of pathogens into the bloodstream . Pediatr Res . 2007 ; 61 ( 5 Pt 1): 588 – 93 . doi: 10.1203/pdr.0b013e3180459f75 17413870

상세보기
24 Choi Y , Saha SK , Ahmed AS , Law PA , Chowdhury MA , Islam M , et al . Routine skin cultures in predicting sepsis pathogens among hospitalized preterm neonates in Bangladesh . Neonatology. 2008 ; 94 ( 2 ): 123 – 31 . doi: 10.1159/000119722 18332641

상세보기
25 Kozuki N , Katz J , Clermont A , Walker N . New option in the Lives Saved Tool (LiST) allows for the conversion of prevalence of small-for-gestational-age and preterm births to prevalence of low birth weight . J Nutr . 2017 Nov ; 147 ( 11 ): 2141S – 6S . doi: 10.3945/jn.117.247767 28904115

상세보기
26 Lee AC , Katz J , Blencowe H , Cousens S , Kozuki N , Vogel JP , et al . National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010 . Lancet Glob Health. 2013 Jul ; 1 ( 1 ): e26 – 36 . doi: 10.1016/S2214-109X(13)70006-8 25103583

상세보기
27 Hammarlund K , Sedin G . Transepidermal water loss in newborn infants. IV. Small for gestational age infants . Acta Paediatr Scand . 1980 ; 69 ( 3 ): 377 – 83 . doi: 10.1111/j.1651-2227.1980.tb07096.x 7376865

상세보기
28 Hammarlund K , Sedin G , Strömberg B . Transepidermal water loss in newborn infants. VIII. Relation to gestational age and post-natal age in appropriate and small for gestational age infants . Acta Paediatr Scand . 1983 ; 72 ( 5 ): 721 – 8 . doi: 10.1111/j.1651-2227.1983.tb09801.x 6637471

상세보기
29 Williams ML , Aszterbaum M , Menon GK , Moser AH , Feingold KR , Hoath SB . Preservation of permeability barrier ontogenesis in the intrauterine growth-retarded fetal rat . Pediatr Res . 1993 ; 33 ( 4 Pt 1): 418 – 24 . doi: 10.1203/00006450-199304000-00020 8479825

상세보기
30 Knowles V , Yajamanyam PK . Physiological weight loss in term newborn infants . Arch Dis Child . 2021 Feb 1 ; 106 ( 2 ): 195 – 7 . doi: 10.1136/archdischild-2020-319158 33023887

상세보기
31 Darmstadt GL , Ahmed S , Ahmed AS , Saha SK . Mechanism for prevention of infection in preterm neonates by topical emollients . Pediatr Infect Dis J . 2014 ; 33 ( 11 ): 1124 – 7 . doi: 10.1097/INF.0000000000000423 24853544

상세보기
32 Shahunja KM , Ahmed T , Hossain I , Mahfuz M , Kendall L , Zhu X , et al . Topical emollient therapy in the management of severe acute malnutrition in under-two children: A randomised controlled clinical trial in Bangladesh . J Glob Health . 2020 ; 10 ( 1 ): 010414 . doi: 10.7189/jogh.10.010414 32509290

상세보기
33 Darmstadt GL , Khan NZ , Rosenstock S , Muslima H , Parveen M , Mahmood W , et al . Impact of emollient therapy for preterm infants in the neonatal period on child neurodevelopment in Bangladesh . J Health Popul Nutr . 2021 ; 40 ( 24 ). doi: 10.1186/s41043-021-00248-9 34039435

상세보기
34 Fallah R , Akhavan Karbasi S , Golestan M , Fromandi M . Sunflower oil versus no oil moderate pressure massage leads to greater increases in weight in preterm neonates who are low birth weight . Early Hum Dev . 2013 ; 89 ( 9 ): 769 – 72 . doi: 10.1016/j.earlhumdev.2013.06.002 23830725

상세보기
35 Vaivre-Douret L , Oriot D , Blossier P , Py A , Kasolter-Péré M , Zwang J . The effect of multimodal stimulation and cutaneous application of vegetable oils on neonatal development in preterm infants: a randomized controlled trial . Child Care Health Dev . 2009 ; 35 ( 1 ): 96 – 105 . doi: 10.1111/j.1365-2214.2008.00895.x 18991972

상세보기
36 Aberg KM , Man M-Q , Gallo RL , Ganz T , Crumrine D , Brown BE , et al . Co-Regulation and interdependence of the mammalian epidermal permeability and antimicrobial barriers . J Invest Dermatol . 2008 ; 128 ( 4 ): 917 – 25 . doi: 10.1038/sj.jid.5701099 17943185

상세보기
37 Elias P , Mao-Qiang M , Thornfeldt C , Feingold K . The Epidermal Permeability Barrier: Effects of Physiologic and Non-physiologic Lipids . In: The Lanolin Book . Hamburg, Germany : Beiersdorf AG ; 1999 . p. 253 – 79 .
38 Prottey C , Hartop PJ , Press M . Correction of the cutaneous manifestations of essential fatty acid deficiency in man by application of sunflower-seed oil to the skin . J Invest Dermatol . 1975 ; 64 ( 4 ): 228 – 34 . doi: 10.1111/1523-1747.ep12510667 1117180

상세보기
39 Hanley K , Jiang Y , He SS , Friedman M , Elias PM , Bikle DD , et al . Keratinocyte differentiation is stimulated by activators of the nuclear hormone receptor PPARalpha . J Invest Dermatol . 1998 ; 110 ( 4 ): 368 – 75 . doi: 10.1046/j.1523-1747.1998.00139.x 9540977

상세보기
40 Schürer N , Schliep V , Williams ML . Differential utilization of linoleic and arachidonic acid by cultured human keratinocytes . Skin Pharmacol . 1995 ; 8 ( 1–2 ): 30 – 40 . doi: 10.1159/000211328 7786523

상세보기
41 Fluhr JW , Man M-Q , Hachem J-P , Crumrine D , Mauro TM , Elias PM , et al . Topical peroxisome proliferator activated receptor activators accelerate postnatal stratum corneum acidification . J Invest Dermatol . 2009 ; 129 ( 2 ): 365 – 74 . doi: 10.1038/jid.2008.218 18704104

상세보기
42 Elias PM . The how, why and clinical importance of stratum corneum acidification . Exp Dermatol . 2017 ; 26 ( 11 ): 999 – 1003 . doi: 10.1111/exd.13329 28266738

상세보기

표제어: PCR

동의어: Packet Collision Rate

용어 설명 출처 목록 (6)

용어 설명: PCR은 세균 특이성이 있는 primer를 이용하여 적은 수의 세균이 있을지라도 쉽게 검출할 수 있는 유용한 방법이며, 이를 이용하여 구강 내 치면세균막이나 타액에서 직접 세균을 검출할 수 있게 되었다[8].

내보내기 구분	파일저장 인쇄 메일전송
구성항목	기본정보 상세정보 관리번호, 논문명, 저널/프로시딩명, 저자 , 발행년, 권, 호, 시작페이지, 끝페이지, 발행기관 관리번호, 논문명, 대등논문명, 저자 , 저널/프로시딩명, 발행기관, 발행년, 발행언어, 권, 호, 시작페이지, 끝페이지, ISBN, ISSN, 주제분야, 키워드, 초록(한글), 초록(영문), 저자(소속기관)
저장형식	Text(ASCII format) Excel format RefWorks Direct Export RIS format (for Reference Manager, ProCite, EndNote), Scholar's Aids, Mendeley
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

연합인증

Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial 원문보기

Abstract ▼ AI-Helper

참고문헌 (42)

이 논문을 인용한 문헌

관련 콘텐츠

원문 보기

원문 URL 링크

오픈액세스(OA) 유형

이 논문과 함께 이용한 콘텐츠

AI-Helper ※ AI-Helper는 오픈소스 모델을 사용합니다.

선택된 텍스트