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NCT03372590 · ClinicalTrials.gov registry record · NA
NEO Rehab for Infants at Risk of Cerebral Palsy
A NA study of Cerebral Palsy and Prematurity, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03372590 is a NA study of Cerebral Palsy and Prematurity that has completed, run by University of Virginia. The registered enrollment target is 14 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03372590, a NA study of Cerebral Palsy and Prematurity, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool. Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants. This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.
Conditions Studied
Interventions
- OTHER Standard of care
- OTHER NICU-based rehabilitation bundle
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-09-02 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03372590
The ClinicalTrials.gov registry entry for NCT03372590 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 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 (94% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.
NCT03372590 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT03372590 about?
NCT03372590 is a clinical study titled "NEO Rehab for Infants at Risk of Cerebral Palsy". Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be ...
What is the current status of trial NCT03372590?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-09-02. Estimated completion is 2019-06-30.
What conditions does trial NCT03372590 study?
This clinical trial studies the following conditions: Cerebral Palsy, Prematurity.
What interventions are being tested in trial NCT03372590?
The interventions under investigation include: Standard of care (OTHER), NICU-based rehabilitation bundle (OTHER).
Who is sponsoring clinical trial NCT03372590?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03372590 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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Related
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