NCT05461404

Emollient Therapy for Premature Infants in Zimbabwe

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

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.

Conditions

• Very Low Birth Weight Infant

Interventions

Type	Name	Description
OTHER	Topical Emollient Therapy	Application of high-linoleate (\>60% linoleic acid) SSO to the epidermis.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-05-31
• Completion: 2025-12-31
• First posted: 2022-07-18
• Last updated: 2023-04-19

Locations

1 site across 1 country: Zimbabwe