Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420531
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-14
Brief Title:
Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 goal of this multi-center randomized parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mLkgday on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation
Detailed Description:
Participants will be randomized once they reach 120 mLkgday Clinicians will be able to increase feeds each day as they see fit until the patient reaches the target goal of 140-160 mLkgday or 180-200 mLkgday They will then maintain this volume until 34 weeks postmenstrual age Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes
Participants will
Have a feeding volume of 180-200 mLkgday or a volume of 140-160 mLkgday until 34 weeks corrected age
Have four body composition assessments with a bioelectrical impedance analyzer throughout study period
Have four stool samples collected throughout study period
Have four maternal breastmilk samples collected and analyzed throughout the study period
Have one blood sample collected at 36 weeks corrected age
Have the option to participate in a follow-up survey completed by parents at 2-3 years of age
Participants will
Have a feeding volume of 180-200 mLkgday or a volume of 140-160 mLkgday until 34 weeks corrected age
Have four body composition assessments with a bioelectrical impedance analyzer throughout study period
Have four stool samples collected throughout study period
Have four maternal breastmilk samples collected and analyzed throughout the study period
Have one blood sample collected at 36 weeks corrected age
Have the option to participate in a follow-up survey completed by parents at 2-3 years of age
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