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NCT06266455 · ClinicalTrials.gov registry record · NA
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
A NA study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06266455: Recruiting NA study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, sponsored by Children's National Research Institute.
NCT06266455 is a NA study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 150 participants, above the 56-participant average among 3 other Very Low Birth Weight Infant trials with a reported enrollment target (168% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06266455, a NA study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment. Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques. Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent
Primary Outcome
Weight gain velocity (grams per kilogram per day)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Standardized Fortification
- DIETARY_SUPPLEMENT Adjustable Fortification
Study Locations (1)
District of Columbia
- Children's National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2034-01 |
| Phase | NA |
What NCT06266455 shows while recruiting
NCT06266455 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 56-participant average among 3 other Very Low Birth Weight Infant trials with a reported enrollment target (168% higher).
The record links to 2 conditions, with Very Low Birth Weight Infant appearing as the primary indexed condition, and to 2 interventions - of which Standardized Fortification is the first listed.
NCT06266455 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06266455 about?
NCT06266455 is a clinical study titled "Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment". Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily...
What is the current status of trial NCT06266455?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-02-08. Estimated completion is 2034-01.
What conditions does trial NCT06266455 study?
This clinical trial studies the following conditions: Very Low Birth Weight Infant, Very Preterm Maturity of Infant.
What interventions are being tested in trial NCT06266455?
The interventions under investigation include: Standardized Fortification (DIETARY_SUPPLEMENT), Adjustable Fortification (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06266455?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06266455 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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