Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-28 @ 6:57 PM
Study NCT ID:
NCT05461404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emollient Therapy for Premature Infants in Zimbabwe
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Emollient Therapy for Improved Survival and Growth of Very Low Birth Weight Infants in Zimbabwe
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: