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NCT02943746 · ClinicalTrials.gov registry record · NA
Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants
A NA study of Premature Infants, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT02943746: Completed NA study of Premature Infants, sponsored by Baylor College of Medicine.
NCT02943746 is a NA study of Premature Infants that has completed, run by Baylor College of Medicine. The registered enrollment target is 118 participants, below the 227-participant average among 4 other Premature Infants trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02943746, a NA study of Premature Infants, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.
Primary Outcome
Linear growth will be measured in centimeters (cm) per week. An average weekly linear growth will be calculated for each patient over the study period.These values will be compared to published standards for age.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Standard Protein Diet
- DIETARY_SUPPLEMENT High Protein Diet
Study Locations (1)
Texas
- Baylor College of Medicine / Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2016-11 |
| Est. Completion | 2021-04-30 |
| Phase | NA |
What the finished NCT02943746 record still lists
NCT02943746 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 227-participant average among 4 other Premature Infants trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Premature Infants appearing as the primary indexed condition, and to 2 interventions - of which Standard Protein Diet is the first listed.
NCT02943746 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02943746 about?
NCT02943746 is a clinical study titled "Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants". While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutr...
What is the current status of trial NCT02943746?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2016-11. Estimated completion is 2021-04-30.
What conditions does trial NCT02943746 study?
This clinical trial studies the following conditions: Premature Infants.
What interventions are being tested in trial NCT02943746?
The interventions under investigation include: Standard Protein Diet (DIETARY_SUPPLEMENT), High Protein Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02943746?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02943746 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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