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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 is a NA study that was terminated before completion, run by MetroHealth Medical Center. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04025021
The ClinicalTrials.gov registry entry for NCT04025021 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Targeted Fortification is the first listed.
NCT04025021 reports 0 study locations.
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.
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