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Emollient Therapy for Premature Infants in Zimbabwe

Primary Purpose

Very Low Birth Weight Infant

Status

Not yet recruiting

Phase

Not Applicable

Locations

Zimbabwe

Study Type

Interventional

Intervention

Topical Emollient Therapy

About this trial

This is an interventional treatment trial for Very Low Birth Weight Infant focused on measuring emollient therapy, sunflower seed oil (SSO), skin barrier, Zimbabwe, neonatal mortality, newborn care, preterm infants, postnatal care, growth

Eligibility Criteria

undefined - 28 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

infants <72 hours of age
weigh 700-1500 at birth
hospitalized at SMCH

Exclusion Criteria:

infants who are moribund and highly likely not to survive despite any intervention
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

Sites / Locations

Sally Mugabe Central Hospital (SMCH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Emollient arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days

This will be an intent-to-treat analysis, using the randomization level rather than the received level of intervention. To estimate the change in mortality rate, we will use a maximum likelihood approach, operationalized as a logistic model with fixed effects for study arm and strata random effects.

Secondary Outcome Measures

Compare growth rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days.

For the secondary analysis of change in growth rate, the quantity of interest is change in weight over the study period as a proportion of the infant's birthweight (g/kg/day). This secondary analysis will use a maximum likelihood approach to both testing and estimation, operationalized as a linear model with fixed effects for the study arm and strata.

Full Information

NCT ID

NCT05461404

First Posted

July 13, 2022

Last Updated

April 17, 2023

Sponsor

Stanford University

Collaborators

University of Zimbabwe, University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05461404

Brief Title

Emollient Therapy for Premature Infants in Zimbabwe

Official Title

Emollient Therapy for Improved Survival and Growth of Very Low Birth Weight Infants in Zimbabwe

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

University of Zimbabwe, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.

Detailed Description

For infants whose parent/caretaker provides written informed consent, the study nurse coordinator on-site will allocate infants to one of two strata (700- <1000 g or 1000-1500 g). Participants within each stratum will be randomly assigned in a 1:1 ratio to one of two treatment groups: 1) high-linoleate SSO, or 2) standard-of-care treatment without use of topical emollients or massage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Very Low Birth Weight Infant

Keywords

emollient therapy, sunflower seed oil (SSO), skin barrier, Zimbabwe, neonatal mortality, newborn care, preterm infants, postnatal care, growth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Infants will be enrolled after informed consent, stratified by birthweight (700- <1000 g, 1000-1500 g) and randomly allocated 1:1 to the two arms of the trial which will be run in parallel.

Masking

None (Open Label)

Masking Description

Due to the visible nature of the intervention, it is not possible to completely mask allocation; thus, the trial will be open-label. However, study physicians will not have access to patient randomization lists.

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Emollient arm

Arm Type

Experimental

Arm Description

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Topical Emollient Therapy

Intervention Description

Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.

Primary Outcome Measure Information:

Title

Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days

Description

Time Frame

Baseline and 28 days

Secondary Outcome Measure Information:

Title

Compare growth rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days.

Description

Time Frame

Baseline and 28 days

Other Pre-specified Outcome Measures:

Title

Estimate a strata specific treatment effect, comparing mortality rates in infants 700- <1000 g or 1000-1500 g treated with SSO vs. control.

Description

This aim will build upon methods used in the primary analysis. To estimate the change in mortality rate, and allowing the treatment effect to vary by strata, we will use a maximum likelihood approach, operationalized as a logistic model with fixed effects for study arm and strata, as well as an interaction term between study arm and strata.

Time Frame

Within 6 months of the end of enrollment

Title

Use residual inclusion modeling to isolate as much as possible the connection between weight gain and mortality.

Description

For the exploratory analysis which aims to estimate the change in rate of mortality attributable to the change in weight, we will use an instrumental variable design. The study's randomization will be the "instrument," the "treatment" will be change in weight, and the "outcome" of interest will be mortality. This exploratory analysis will use a residual inclusion model approach to both testing and estimation, operationalized as a linear model in the first stage of the residual model and a logistic model in the second stage.

Time Frame

Within 6 months of the end of enrollment

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: infants <72 hours of age weigh 700-1500 at birth hospitalized at SMCH Exclusion Criteria: infants who are moribund and highly likely not to survive despite any intervention significant breaches in their skin barrier conditions indicating failure to gain weight critically ill (definition below): Oxygen saturation <88% on oxygen therapy AND ≥2 of the following conditions: respiratory rate <20 or >100 breaths per minute apnea requiring bag-mask ventilation 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Darmstadt, MD, MS

Phone

650-724-6014

gdarmsta@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hilda A. Mujuru, MBChB, MMed, MSc

Organizational Affiliation

University of Zimbabwe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sally Mugabe Central Hospital (SMCH)

City

Harare

Country

Zimbabwe

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hilda A Mujuru, MBChB, MMed, MSc

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34386216

Citation

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.

Results Reference

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PubMed Identifier

12113324

Citation

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.

Results Reference

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PubMed Identifier

33961715

Citation

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.

Results Reference

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PubMed Identifier

7373078

Citation

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.

Results Reference

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PubMed Identifier

1252336

Citation

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.

Results Reference

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PubMed Identifier

15295221

Citation

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.

Results Reference

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PubMed Identifier

34982820

Citation

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.

Results Reference

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PubMed Identifier

15781099

Citation

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.

Results Reference

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PubMed Identifier

18310201

Citation

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.

Results Reference

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PubMed Identifier

25637007

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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