Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-25 @ 1:14 PM
Study NCT ID:
NCT04330859
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2019-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, 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.
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 acceptability, feasibility (practicality) and fidelity (adherence, exposure and engagement) of a multimodal GA appropriate rehabilitation program during NICU hospitalization compared to standard of care. The investigators will evaluate:
* Acceptability using recruitment, refusal, retention, and follow-up rates as well as weekly interviews with parental participants
* Feasibility (practicality) using direct observations and weekly interviews with parental participants
* Fidelity (adherence, exposure and engagement) using visitation data, activity logs, direct observations, and weekly interviews.
Aim 2: Examine the effect of a multimodal NICU-based rehabilitation program on short-term motor outcomes (general movements, cranial nerves, posture, movements, tone, and reflexes) of premature infants at risk for cerebral palsy (CP) at discharge from the NICU and at 3 months corrected age. The investigators hypothesize that this type of GA appropriate multimodal NICU-based rehabilitation program will positively impact short-term motor outcomes by normalizing general movements and improving TIMP and HINE scores.
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 acceptability, feasibility (practicality) and fidelity (adherence, exposure and engagement) of a multimodal GA appropriate rehabilitation program during NICU hospitalization compared to standard of care. The investigators will evaluate:
* Acceptability using recruitment, refusal, retention, and follow-up rates as well as weekly interviews with parental participants
* Feasibility (practicality) using direct observations and weekly interviews with parental participants
* Fidelity (adherence, exposure and engagement) using visitation data, activity logs, direct observations, and weekly interviews.
Aim 2: Examine the effect of a multimodal NICU-based rehabilitation program on short-term motor outcomes (general movements, cranial nerves, posture, movements, tone, and reflexes) of premature infants at risk for cerebral palsy (CP) at discharge from the NICU and at 3 months corrected age. The investigators hypothesize that this type of GA appropriate multimodal NICU-based rehabilitation program will positively impact short-term motor outcomes by normalizing general movements and improving TIMP and HINE scores.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R03HD097727 | NIH | None | https://reporter.nih.gov/quic… | View |