Trials / Completed
CompletedNCT04283799
Using a New Human Milk Fortifier to Optimize Feeding
Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Children's Hospital of Fudan University · Academic / Other
- Sex
- All
- Age
- 1 Day
- Healthy volunteers
- Not accepted
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 28+0 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | A new human milk fortifier | Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF |
Timeline
- Start date
- 2020-03-16
- Primary completion
- 2021-04-23
- Completion
- 2021-04-23
- First posted
- 2020-02-25
- Last updated
- 2021-06-09
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04283799. Inclusion in this directory is not an endorsement.