Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05675397
Status:
RECRUITING
Last Update Posted:
2023-01-09
First Post:
2022-12-14
Brief Title:
Preterm Donor Human Milk Supplementation of Mothers Own Milk in VLBW Infants
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Supplementation of Mothers Own Milk With Preterm Donor Human Milk Impact on Morbidity and Growth in Very Low Birth Weight Infants
Status:
RECRUITING
Status Verified Date:
2022-12
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:
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight VLBW infants with Mothers own milk MOM supplemented with either preterm PDM or term donor milk TDM when MOM is insufficient has a positive impact on infants protein intake growth and morbidity
Detailed Description:
Mothers own milk MOM is the optimal nutrition for preterm infants When MOM is not sufficient pasteurized donor milk DM is the best alternative according to current recommendations Donor milk is primarily derived from mothers of term-born infants for the first six months of lactation However this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy
The investigators hypothesized that feeding VLBW infants with preterm donor milk PDM in combination with MOM may positively influence the protein intake and consequently the infants growth The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition growth and morbidity in VLBW infants
The investigators hypothesized that feeding VLBW infants with preterm donor milk PDM in combination with MOM may positively influence the protein intake and consequently the infants growth The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition growth and morbidity in VLBW infants
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