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NCT04025021 · ClinicalTrials.gov registry record · NA
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
A NA study, sponsored by MetroHealth Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04025021: Clinical Trial NA study, sponsored by MetroHealth Medical Center.
NCT04025021 is a NA study that was terminated before completion, run by MetroHealth Medical Center. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04025021, a NA study, was terminated before completion, sponsored by MetroHealth Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.
Primary Outcome
Body composition will be measured by air displacement plethysmography (PEAPod). As standardized assessment of body composition is relatively new in the preterm infant population, we are using clinical judgment to determine that a difference in fat free mass z-score (from data from Norris T, 2019) of 0.5 is clinically significant.
Interventions
- DIETARY_SUPPLEMENT Targeted Fortification
- DEVICE The Miris Human Milk Analyzer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
Why NCT04025021 stopped before completion
NCT04025021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Targeted Fortification is the first listed.
NCT04025021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04025021 about?
NCT04025021 is a clinical study titled "Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU". This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control gro...
What is the current status of trial NCT04025021?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2019-10-01. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT04025021?
The interventions under investigation include: Targeted Fortification (DIETARY_SUPPLEMENT), The Miris Human Milk Analyzer (DEVICE).
Who is sponsoring clinical trial NCT04025021?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04025021's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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