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NCT03977259 · ClinicalTrials.gov registry record · NA
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
A NA study of Preterm Birth and Neurodevelopmental Disorders, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT03977259: Active NA study of Preterm Birth and Neurodevelopmental Disorders, sponsored by Brigham and Women's Hospital.
NCT03977259 is a NA study of Preterm Birth and Neurodevelopmental Disorders that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 130 participants, below the 4,406-participant average among 39 other Preterm Birth trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03977259, a NA study of Preterm Birth and Neurodevelopmental Disorders, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
Primary Outcome
Weight z-score
Conditions Studied
Interventions
- OTHER Individually targeted fortification
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2020-01-31 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What the registry record for NCT03977259 still lists
NCT03977259 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 4,406-participant average among 39 other Preterm Birth trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Individually targeted fortification is the first listed.
NCT03977259 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03977259 about?
NCT03977259 is a clinical study titled "Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development". This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (c...
What is the current status of trial NCT03977259?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2020-01-31. Estimated completion is 2027-08-31.
What conditions does trial NCT03977259 study?
This clinical trial studies the following conditions: Preterm Birth, Neurodevelopmental Disorders, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality.
What interventions are being tested in trial NCT03977259?
The interventions under investigation include: Individually targeted fortification (OTHER).
Who is sponsoring clinical trial NCT03977259?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03977259 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Preterm Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03977259's enrollment target sits among peer trials
130 24th of 39 higher than 16 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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