NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Condition: Cerebral Palsy; Prematurity; Early Intervention; Family Centered Care
MeSH terms: Paralysis; Cerebral Palsy; Premature Birth
Study type: Interventional

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.
    

Intervention name(s): NeoRehab Bundle; Routine care
Intervention type(s): Other; Other
Intervention description(s): 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); 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; prematurity; early intervention; parent-driven; brain plasticity; motor outcome