Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04283799
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2020-02-23
Brief Title:
Using a New Human Milk Fortifier to Optimize Feeding
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants a Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-06
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:
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants
Detailed Description:
Infants with fortified human milk feeding have the same rate of growth lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization However the currently human milk fortifiers HMF have some nutritional components defects to meet the needs of very preterm infants New HMF provide higher protein and fat which are safe and well tolerate to use in preterm infants Study on safety and efficacy of the new HMF is insufficient in Chinese preterm infant population Our aims are to compare the safety and efficacy of a new HMF and other HMF used before in very preterm infants Very low preterm infants with birth weights of 1000-1499g and gestational age 280 weeks to 31 6 weeks are included Infants feeding with new HMF are in the experimental group Infants feeding with other HMF are in the control group a historically control group Physical growth nutritional indexes incidence of feeding intolerance and time to achieve full enteral feeding are compared between the two groups
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