- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330859
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy
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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)
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PLACEBO_COMPARATOR: Routine care
Routine care per unit guidelines
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental satisfaction of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy.
Time Frame: 2 years
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The following measure will be used to measure study parental satisfaction: Weekly interviews with parental participants |
2 years
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Acceptability of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy.
Time Frame: 2 years
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The following measure will be used to measure study acceptability: Recruitment rates |
2 years
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Retention rates of a parent-driven NeoRehab bundle in preterm infants at risk for cerebral palsy.
Time Frame: 2 years
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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
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Adherence rates to study protocol
Time Frame: 2 years
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Activity logs
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2 years
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Impact of the NeoRehab bundle on motor performance using the Test of Infant Motor Performance (TIMP)
Time Frame: 2 years
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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.
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2 years
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Impact of the NeoRehab bundle on neurologic function as assessed by the Hammersmith Infant Neurological Examination (HINE).
Time Frame: 2 years
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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.
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2 years
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Impact of the NeoRehab bundle on infants' general movements.
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVirginia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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