NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Not Applicable

Completed

Conditions: Cerebral Palsy
Early Intervention
Prematurity
Family Centered Care

Interventions: Other: Routine care
Other: NeoRehab Bundle

Registration Number: NCT04330859

Lead Sponsor: University of Virginia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care	Routine care	Routine care per unit guidelines
Intervention	NeoRehab Bundle	Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy

Primary Outcome Measures

Name	Time	Method
Adherence Rates	from study enrollment (day 1) to study discharge	Adherence rates were monitored by daily activity logs of interventions from enrollment day 1 to discharge for each visit day
Acceptability	from day 1 of study screening through end of screening (approximately 1 year and3 months).	The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period
Retention Rates	From discharge to 3 months follow-up	The following measure will be used to assess the retention rate of study participants: - Rate of follow-up at the 3 month outpatient visit
Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP)	3 months	Motor outcomes will be assessed at NICU discharge and at 3 months using the Test of Infant Motor Performance (TIMP); 3 months outcome reported. TIMP score range = 0-142; lower scores indicate worse motor performance
Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE).	3 months	Neurologic function will be assessed at NICU discharge and at 3 months postmenstrual age using the Hammersmith Infant Neurological Examination (HINE) instrument, 3 months outcome reported. 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. HINE score range = 0-78 (with lower score indicating lower motor performance). The HINE has a sensitivity of 90% for prediction of motor outcome.
Percent Abnormal General Movements	3 months	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.