Very Low Birth Weight Infant
Conditions
Keywords
emollient therapy, sunflower seed oil (SSO), skin barrier, Zimbabwe, neonatal mortality, newborn care, preterm infants, postnatal care, growth
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.
Interventions
OTHERTopical Emollient Therapy
Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.
Sponsors
University of Zimbabwe
University of California, San Francisco
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimate a strata specific treatment effect, comparing mortality rates in infants 700- <1000 g or 1000-1500 g treated with SSO vs. control. | 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. |
| Use residual inclusion modeling to isolate as much as possible the connection between weight gain and mortality. | 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. |
Countries
Zimbabwe
Contacts
Primary ContactGary Darmstadt, MD, MS
Outcome results
None listed