Trial Outcomes & Findings for NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy (NCT NCT04330859)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

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

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Parent-driven Multimodal Interventions Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy 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 (Control Group) Routine care per unit guidelines 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
Overall Study STARTED	36	34
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=34 Participants Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy 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 n=33 Participants Routine care per unit guidelines 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	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.02 weeks STANDARD_DEVIATION 2.70 • n=5 Participants	28.75 weeks STANDARD_DEVIATION 2.68 • n=7 Participants	28.39 weeks STANDARD_DEVIATION 2.69 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Study Acceptability n=99 Participants Acceptability of enrollment into study	Control Routine care
Acceptability	70 Participants	—

PRIMARY outcome

Timeframe: From discharge to 3 months follow-up

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

Outcome measures

Outcome measures
Measure	Study Acceptability n=70 Participants Acceptability of enrollment into study	Control Routine care
Retention Rates	73 percentage of participants	—

PRIMARY outcome

Timeframe: from study enrollment (day 1) to study discharge

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

Outcome measures

Outcome measures
Measure	Study Acceptability n=32 Participants Acceptability of enrollment into study	Control n=33 Participants Routine care
Adherence Rates	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Study Acceptability n=22 Participants Acceptability of enrollment into study	Control n=21 Participants Routine care
Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP)	86 score on a scale Interval 73.0 to 100.0	91 score on a scale Interval 83.0 to 99.0

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Study Acceptability n=25 Participants Acceptability of enrollment into study	Control n=26 Participants Routine care
Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE).	58.8 score on a scale Standard Deviation 7.2	57.2 score on a scale Standard Deviation 11.2

PRIMARY outcome

Timeframe: 3 months

Population: Abnormal general movements = absent fidgety classification

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.

Outcome measures

Outcome measures
Measure	Study Acceptability n=23 Participants Acceptability of enrollment into study	Control n=28 Participants Routine care
Percent Abnormal General Movements	57 percentage of participants	54 percentage of participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Santina Zanelli

University of Virginia Children's Hospital

Phone: 4349242697

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place