N/A
N=70
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Cerebral Palsy · Prematurity · Early Intervention · Family Centered Care
Bottom Line
View on ClinicalTrials.gov: NCT04330859 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Acceptability — 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeoRehab Bundle (Other); Routine care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability |
70 | — |
| PRIMARY Retention Rates |
73 | — |
| PRIMARY Adherence Rates |
0; 0 | — |
| PRIMARY Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP) |
86; 91 | — |
| PRIMARY Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE). |
58.8; 57.2 | 0.0543 |
| PRIMARY Percent Abnormal General Movements |
57; 54 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04330859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.