Emollient Therapy for Premature Infants in Zimbabwe

April 17, 2023 updated by: Gary Darmstadt, Stanford University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • Sally Mugabe Central Hospital (SMCH)
        • Contact:
          • Hilda A Mujuru, MBChB, MMed, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Topical Emollient Therapy
Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days
Time Frame: Baseline and 28 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.
Baseline and 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare growth rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days.
Time Frame: Baseline and 28 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.
Baseline and 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate a strata specific treatment effect, comparing mortality rates in infants 700- <1000 g or 1000-1500 g treated with SSO vs. control.
Time Frame: Within 6 months of the end of enrollment
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.
Within 6 months of the end of enrollment
Use residual inclusion modeling to isolate as much as possible the connection between weight gain and mortality.
Time Frame: Within 6 months of the end of enrollment
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.
Within 6 months of the end of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

University of California, San Francisco
University of Zimbabwe

Investigators

  • Principal Investigator: Hilda A. Mujuru, MBChB, MMed, MSc, University of Zimbabwe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

May 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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