Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
520 participants
INTERVENTIONAL
2023-08-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Emollient arm
Infants will receive gentle, hygienic whole-body massage by trained nurses (not parents or other family members) with 3g of SSO per kg of body weight - a dose sufficient to saturate the skin - three times daily for the first 14 days and twice daily thereafter during the duration of their stay in the hospital until death, discharge or through day 28 after birth.
Topical Emollient Therapy
Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.
Control arm
Infants in the control group will receive the standard of care for infants in the neonatal care unit, which does not include use of topical emollients or massage (i.e., family members will not be allowed to apply skin care products to their infants), or other particular measures to prevent skin breakdown or to modulate skin barrier function.
No interventions assigned to this group
Interventions
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Topical Emollient Therapy
Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.
Eligibility Criteria
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Inclusion Criteria
* weigh 700-1500 at birth
* hospitalized at SMCH
Exclusion Criteria
* significant breaches in their skin barrier
* conditions indicating failure to gain weight
* critically ill (definition below):
1. Oxygen saturation \<88% on oxygen therapy AND ≥2 of the following conditions:
2. respiratory rate \<20 or \>100 breaths per minute
3. apnea requiring bag-mask ventilation
4. heart rate \<100 or \>200 beats per minute
* congenital syphilis
* hydrops fetalis
* a life-threatening congenital anomaly or major surgical condition requiring intervention
* generalized skin disease or a structural defect involving \>5% body surface area likely to produce a defect in epidermal barrier function
28 Days
ALL
Yes
Sponsors
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University of Zimbabwe
OTHER
University of California, San Francisco
OTHER
Stanford University
OTHER
Responsible Party
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Gary Darmstadt
Professor of Pediatrics
Principal Investigators
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Hilda A. Mujuru, MBChB, MMed, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Zimbabwe
Locations
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Sally Mugabe Central Hospital (SMCH)
Harare, , Zimbabwe
Countries
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Central Contacts
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Facility Contacts
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Hilda A Mujuru, MBChB, MMed, MSc
Role: primary
References
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Fischer N, Darmstadt GL, Shahunja KM, Crowther JM, Kendall L, Gibson RA, Ahmed T, Relman DA. Topical emollient therapy with sunflower seed oil alters the skin microbiota of young children with severe acute malnutrition in Bangladesh: A randomised, controlled study. J Glob Health. 2021 Jul 17;11:04047. doi: 10.7189/jogh.11.04047. eCollection 2021.
Darmstadt GL, Mao-Qiang M, Chi E, Saha SK, Ziboh VA, Black RE, Santosham M, Elias PM. 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.
Cleminson J, McGuire W. Topical emollient for preventing infection in preterm infants. Cochrane Database Syst Rev. 2021 May 7;5(5):CD001150. doi: 10.1002/14651858.CD001150.pub4.
Elias PM, Brown BE, Ziboh VA. The permeability barrier in essential fatty acid deficiency: evidence for a direct role for linoleic acid in barrier function. J Invest Dermatol. 1980 Apr;74(4):230-3. doi: 10.1111/1523-1747.ep12541775.
Prottey C, Hartop PJ, Black JG, McCormack JI. The repair of impaired epidermal barrier function in rats by the cutaneous application of linoleic acid. Br J Dermatol. 1976 Jan;94(1):13-21. doi: 10.1111/j.1365-2133.1976.tb04336.x.
Darmstadt GL, Badrawi N, Law PA, Ahmed S, Bashir M, Iskander I, Al Said D, El Kholy A, Husein MH, Alam A, Winch PJ, Gipson R, Santosham M. Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J. 2004 Aug;23(8):719-25. doi: 10.1097/01.inf.0000133047.50836.6f.
Kumar V, Kumar A, Mishra S, Kan P, Ashraf S, Singh S, Blanks KJH, Baiocchi M, Limcaoco M, Ghosh AK, Kumar A, Krishna R, Stevenson DK, Tian L, Darmstadt GL; Shivgarh Emollient Research Group. Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial. Am J Clin Nutr. 2022 Apr 1;115(4):1092-1104. doi: 10.1093/ajcn/nqab430.
Darmstadt GL, Saha SK, Ahmed AS, Chowdhury MA, Law PA, Ahmed S, Alam MA, Black RE, Santosham M. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial. Lancet. 2005 Mar 19-25;365(9464):1039-45. doi: 10.1016/S0140-6736(05)71140-5.
Darmstadt GL, Saha SK, Ahmed AS, Ahmed S, Chowdhury MA, Law PA, Rosenberg RE, Black RE, Santosham M. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial. Pediatrics. 2008 Mar;121(3):522-9. doi: 10.1542/peds.2007-0213.
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 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.
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(Suppl 3):S31. doi: 10.1186/1471-2458-13-S3-S31. Epub 2013 Dec 20.
Kumar A, Mishra S, Singh S, Ashraf S, Kan P, Ghosh AK, Kumar A, Krishna R, Stevenson DK, Tian L, Elias PM, Darmstadt GL, Kumar V; Shivgarh Emollient Research Group. Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003680. doi: 10.1371/journal.pmed.1003680. eCollection 2021 Sep.
Hui A, Chimhini G, Saungweme M, Kaisi D, Munetsi E, Mujuru HA, Darmstadt GL. Postnatal care and acceptability of emollient therapy in very low birthweight infants in Harare, Zimbabwe: a qualitative analysis. BMC Pediatr. 2024 Mar 16;24(1):187. doi: 10.1186/s12887-024-04661-x.
Other Identifiers
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66546
Identifier Type: -
Identifier Source: org_study_id
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