Emollient Therapy for Premature Infants in Zimbabwe

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

Detailed Description
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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.

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

Conditions
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Very Low Birth Weight Infant

Intervention / Treatment
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* Other: Topical Emollient Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emollient arm<br>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<br>* Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.<br>|
| No Intervention: Control arm<br>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?
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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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emollient therapy, sunflower seed oil (SSO), skin barrier, Zimbabwe, neonatal mortality, newborn care, preterm infants, postnatal care, growth