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NCT01936246 · ClinicalTrials.gov registry record · NA
Protein Supplementation in Infants With Brain Injury
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01936246: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01936246 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01936246, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. Both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation. Protein supplementation will continue for the first 12 months of age. Growth parameters, such as weight, length, and head circumference, will be measured while the infant is the NICU. Head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.
Interventions
- DIETARY_SUPPLEMENT Increased protein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01936246 record still lists
NCT01936246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Increased protein is the first listed.
NCT01936246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01936246 about?
NCT01936246 is a clinical study titled "Protein Supplementation in Infants With Brain Injury". To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhag...
What is the current status of trial NCT01936246?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2012-08. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01936246?
The interventions under investigation include: Increased protein (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01936246?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01936246's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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