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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 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 4,626-participant average among 37 other Preterm Birth trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03977259
The ClinicalTrials.gov registry entry for NCT03977259 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,626-participant average among 37 other Preterm Birth trials with a reported enrollment target (97% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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, Nutrition Disorder, Infant, Breast Milk Expression, 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.
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