NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330859
• Other study ID #: UVirginia
• Status: Completed
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 1, 2021
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Palsy
• Early Intervention
• Family Centered Care
• Paralysis
• Premature Birth
• Prematurity

Intervention

Other:
• NeoRehab Bundle
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 care
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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Adherence rates to study protocol	Activity logs	2 years
Primary	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
Primary	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
Primary	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