Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
Public ClinicalTrials.gov record NCT04025021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Targeted Fortification of Human Breast Milk and Adjustment of TPN for Very Low Birth Weight Infants to Optimize Growth and Nutrition Using the Miris Mid-infrared Human Milk Analyzer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04025021
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Interventions
- Targeted Fortification Dietary Supplement
- The Miris Human Milk Analyzer Device
Dietary Supplement · Device
Eligibility (public fields only)
- Age range
- Up to 6 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2019
- Primary completion
- Mar 30, 2021
- Completion
- Mar 30, 2021
- Last update posted
- Feb 22, 2023
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04025021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04025021 live on ClinicalTrials.gov.