NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Conditions
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Cerebral Palsy, Prematurity, Early Intervention, Family Centered Care

Intervention / Treatment
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* Other: NeoRehab Bundle
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy | Other: NeoRehab Bundle<br>* The NICU rehabilitation program includes six multimodal, GA appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy)<br>|
| Placebo Comparator: Routine care<br>Routine care per unit guidelines | Other: Routine care<br>* Routine NICU care including talking, touching and holding the participant per unit guideline as well as physical therapy, occupational therapy, and speech therapy per unit guideline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental satisfaction of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy. | The following measure will be used to measure study parental satisfaction: Weekly interviews with parental participants | 2 years | 
| Acceptability of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy. | The following measure will be used to measure study acceptability: Recruitment rates | 2 years | 
| Retention rates of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy. | The following measure will be used to assess the retention rate of study participants: - Rate of follow-up at the 3 month outpatient visit | 2 years | 
| Adherence rates to study protocol | Activity logs | 2 years | 
| Impact of the NeoRehab bundle on motor performance using the Test of Infant Motor Performance (TIMP) | Motor outcomes will be assessed at NICU discharge and at 3 months using the Test of Infant Motor Performance (TIMP). The lower the score the poorer the motor function. | 2 years | 
| Impact of the NeoRehab bundle on neurologic function as assessed by the Hammersmith Infant Neurological Examination (HINE). | Neurologic function will be assessed at NICU discharge and at 3 months postmenstrual age using the Hammersmith Infant Neurological Examination (HINE) instrument. The HINE is a 26 items scale that evaluates cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Lower the score the poorer the motor function. The HINE has a sensitivity of 90% for prediction of motor outcome. | 2 years | 
| Impact of the NeoRehab bundle on infants' general movements. | The impact of the intervention on the infants' general movement will be assessed at NICU discharge and at 3 months postmenstrual age using the general movement assessment (GMA) tool. The GMA has been shown to reliably identify infants at high risk for CP and can be implemented shortly after birth making it an ideal screening tool for preterm infants. Cramped-synchronized writhing general movements followed by absent fidgety general movements is a movement pattern that has been shown to be highly specific of later development of cerebral palsy. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, prematurity, early intervention, parent-driven, brain plasticity, motor outcome