Trials / Completed
CompletedNCT03604042
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 23 Weeks – 32 Weeks
- Healthy volunteers
- Not accepted
Summary
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Protein fortifier | Protein Fortifier to be added to Fortified human milk according to feeding regimen |
Timeline
- Start date
- 2017-10-09
- Primary completion
- 2020-02-10
- Completion
- 2020-02-10
- First posted
- 2018-07-27
- Last updated
- 2020-03-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03604042. Inclusion in this directory is not an endorsement.