Emollient Therapy for Premature Infants in Zimbabwe

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05461404

Collaborator

University of Zimbabwe (Other), University of California, San Francisco (Other)

520

Enrollment

Location

Arms

Anticipated Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Very Low Birth Weight Infant	Other: Topical Emollient Therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

520 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emollient arm 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 Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.
No Intervention: Control arm 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.

Arm

Intervention/Treatment

Experimental: Emollient arm

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

Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.

No Intervention: Control arm

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.

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts 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):

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