Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Targeted Fortification of Donor Breast Milk in Preterm Infants
NCT04294368 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT 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)
Study Locations (1)
New York
- Columbia University Medical Center/ New York - Presbyterian — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2026-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04294368
The ClinicalTrials.gov registry entry for NCT04294368 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Prematurity; Extreme appearing as the primary indexed condition, and to 5 interventions — of which Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04294368 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04294368 about?
NCT04294368 is a clinical study titled "Targeted Fortification of Donor Breast Milk in Preterm Infants". 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 in...
What is the current status of trial NCT04294368?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-03-09. Estimated completion is 2026-03.
What conditions does trial NCT04294368 study?
This clinical trial studies the following conditions: Prematurity; Extreme, Growth Failure, Growth Retardation, Failure to Thrive in Newborn, Infant Nutrition Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04294368?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04294368?
This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04294368 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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