NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

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University of Virginia

Status

Completed

Conditions

Family Centered Care
Prematurity
Cerebral Palsy
Early Intervention

Treatments

Other: NeoRehab Bundle
Other: Routine care

Study type

Interventional

Funder types

Other

Identifiers

NCT04330859
UVirginia

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

23 to 32 weeks old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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