Status:
COMPLETED
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cerebral Palsy
Prematurity
Eligibility:
All Genders
23-32 years
Phase:
NA
Brief 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, ...
Detailed Description
The two following specific aims will be tested: Aim 1: Enroll 60 preterm infants (\<32 weeks' gestation and/or ≤1500 grams) with abnormal GMA into a pilot randomized control trial to evaluate the acc...
Eligibility Criteria
Inclusion
- GA at birth: ≤32 weeks gestation and/or birthweight ≤1500 grams
- Infants 7 days or older
- Ability of parents or identified designated surrogate (e.g. grandparent) to perform the interventions
- Abnormal writhing GMs defined by the presence of a poor repertoire pattern on 2 consecutive assessments or the presence of a cramped-synchronized pattern on any assessment
Exclusion
- Clinically unstable (requiring high frequency mechanical ventilation, vasopressor support, need for continuous intravenous pain or sedation medication)
- If their parents do not speak English
- If parental participation is hindered (e.g. incarceration).
Key Trial Info
Start Date :
May 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04330859
Start Date
May 25 2019
End Date
August 1 2021
Last Update
October 15 2024
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908