Targeted Fortification of Donor Breast Milk in Preterm Infants
Public ClinicalTrials.gov record NCT04294368. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Study identification
- NCT ID
- NCT04294368
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid Dietary Supplement
- Similac Liquid Protein Fortifier Dietary Supplement
- Nestle Microlipid Dietary Supplement
- Medica Nutrition SolCarb Dietary Supplement
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) Dietary Supplement
- Similac Liquid Protein Fortifier (Targeted Fortification) Dietary Supplement
- Nestle Microlipid (Targeted Fortification) Dietary Supplement
- Medica Nutrition SolCarb (Targeted Fortification) Dietary Supplement
- Analysis with Miris (AB) Human Milk Analyzer Other
Dietary Supplement · Other
Eligibility (public fields only)
- Age range
- 1 Day to 21 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2020
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
- Last update posted
- Apr 6, 2026
2020 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Columbia University Medical Center/ New York - Presbyterian | New York | New York | 10032 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04294368, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04294368 live on ClinicalTrials.gov.