The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.
Sally Mugabe Central Hospital (SMCH)
Harare, Zimbabwe
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.
Time frame: Baseline and 28 days
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.
Time frame: Baseline and 28 days
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