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NCT04330859 · ClinicalTrials.gov registry record · NA
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
A NA study of Cerebral Palsy and Prematurity, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04330859 is a NA study of Cerebral Palsy and Prematurity that has completed, run by University of Virginia. The registered enrollment target is 70 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04330859, a NA study of Cerebral Palsy and Prematurity, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy). Using the general movement assessment (GMA) instrument, the investigators will determine the effects of this program on short-term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes) in premature infants (≤32 week's gestation and/or ≤1500 grams birthweight) identified as at-risk for CP. The short-term motor outcomes will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments. This novel program will be applied during the neonatal intensive care unit (NICU) hospitalization when the brain is highly plastic and actively developing with the goal to mitigate severity of brain injury and its impact on development.
Conditions Studied
Interventions
- OTHER Routine care
- OTHER NeoRehab Bundle
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-05-25 |
| Est. Completion | 2021-08-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04330859
The ClinicalTrials.gov registry entry for NCT04330859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (69% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 2 interventions - of which Routine care is the first listed.
NCT04330859 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT04330859 about?
NCT04330859 is a clinical study titled "NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy". The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, ...
What is the current status of trial NCT04330859?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2019-05-25. Estimated completion is 2021-08-01.
What conditions does trial NCT04330859 study?
This clinical trial studies the following conditions: Cerebral Palsy, Prematurity, Early Intervention, Family Centered Care.
What interventions are being tested in trial NCT04330859?
The interventions under investigation include: Routine care (OTHER), NeoRehab Bundle (OTHER).
Who is sponsoring clinical trial NCT04330859?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04330859 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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