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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: Completed NA study of Cerebral Palsy and Prematurity, sponsored by University of Virginia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period
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 |
What the finished NCT04330859 record still lists
NCT04330859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (69% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cerebral Palsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04330859's enrollment target sits among peer trials
70 33rd of 91 higher than 59 of 91 other Cerebral Palsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cerebral Palsy 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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