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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 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01936246
The ClinicalTrials.gov registry entry for NCT01936246 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Increased protein is the first listed.
NCT01936246 reports 0 study locations.
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.
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