NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

NCT04330859 | Completed Results

• 2 other identifiers: UVirginiaR03HD097727
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Prematurity; Early Intervention; Family Centered Care

Keywords

cerebral palsy; prematurity; early intervention; parent-driven; brain plasticity; motor outcome

Outcome Measures

Primary Outcomes (6)

• Acceptability

  The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period

  from day 1 of study screening through end of screening (approximately 1 year and3 months).

• Retention Rates

  The following measure will be used to assess the retention rate of study participants: \- Rate of follow-up at the 3 month outpatient visit

  From discharge to 3 months follow-up

• Adherence Rates

  Adherence rates were monitored by daily activity logs of interventions from enrollment day 1 to discharge for each visit day

  from study enrollment (day 1) to study discharge

• 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); 3 months outcome reported. TIMP score range = 0-142; lower scores indicate worse motor performance

  3 months

• 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, 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.

  3 months

• Percent Abnormal 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.

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy

Other: NeoRehab Bundle

Routine care

PLACEBO COMPARATOR

Routine care per unit guidelines

Other: Routine care

Interventions

NeoRehab Bundle OTHER

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)

Intervention

Routine care OTHER

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

Routine care

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related 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.

  PMID: 35110644 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Lower than expected follow-up rates due to covid-19 restrictions

Results Point of Contact

• Title: Santina Zanelli
• Organization: University of Virginia Children's Hospital

sz5d@virginia.edu

4349242697

Study Officials

• santina zanelli, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neonatology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: April 2, 2020
• Study Start: May 25, 2019
• Primary Completion: October 10, 2020
• Study Completion: August 1, 2021
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)