Clinical trial NCT04330859: NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Official title: NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Prematurity
Early Intervention
Family Centered Care
Keywords: cerebral palsy
prematurity
early intervention
parent-driven
brain plasticity
motor outcome
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Acceptability
timeFrame: from day 1 of study screening through end of screening (approximately 1 year and3 months).
measure: Retention Rates
timeFrame: From discharge to 3 months follow-up
measure: Adherence Rates
timeFrame: from study enrollment (day 1) to study discharge
measure: Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP)
timeFrame: 3 months
measure: Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE).
timeFrame: 3 months
measure: Percent Abnormal General Movements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: santina zanelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Letzkus L, Conaway M, Miller-Davis C, Darring J, Keim-Malpass J, Zanelli S. A feasibility randomized controlled trial of a NICU rehabilitation program for very low birth weight infants. Sci Rep. 2022 Feb 2;12(1):1729. doi: 10.1038/s41598-022-05849-w.