An interventional study of Topical Emollient Therapy in Very Low Birth Weight Infant, sponsored by Stanford University. Not yet recruiting at 1 site in Zimbabwe. Open to participants aged Up to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.
This study's planned enrollment of 520 is above the median of 170 across 117 interventional studies indexed under Birth Weight.
Browse Birth Weight studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
critically ill (definition below):
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
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.
Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.
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
Estimate a strata specific treatment effect, comparing mortality rates in infants 700- <1000 g or 1000-1500 g treated with SSO vs. control.
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.
Time frame: 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.
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.
Time frame: Within 6 months of the end of enrollment
Plan to share: No
Start is estimated for Aug 2023; primary completion for May 2025, 21 months later.
Of 43 non-industry interventional studies with no phase under Birth Weight, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 36. This study's planned 21 months is close to that.
Counting every sponsor, half of 44 studies reached it within 19 months; a quarter within 15 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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