Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207071
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-01-05
Brief Title:
Early DHAARA Supplementation in Growth-restricted Very Preterm Infants A Randomized Clinical Trial
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Early DHA Supplementation in Growth-restricted Very Preterm Infants A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Growth-restricted very preterm infants VPT are born without adequate fat mass FM deposits and low docosahexaenoic acid DHA concentrations They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth One promising approach to mitigate these issues is enteral DHA supplementation However it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants To address this question we propose a masked randomized clinical trial involving 152 VPT infants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None