Emollient Therapy for Premature Infants in Zimbabwe

Not Applicable

Not yet recruiting

• Conditions: Very Low Birth Weight Infant
• Interventions: Other: Topical Emollient Therapy

• Registration Number: NCT05461404
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Study Start: 2023-08-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emollient arm	Topical Emollient Therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sally Mugabe Central Hospital (SMCH); 🇿🇼 Harare, Zimbabwe