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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD097727 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy |
|
| Routine care | Placebo Comparator | Routine care per unit guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| santina zanelli, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35110644 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
70 patients consented and enrolled. Not all patients completed all portions of the studies resulting in different numbers for specific outcomes
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period | Posted | Count of Participants | Participants | from day 1 of study screening through end of screening (approximately 1 year and3 months). |
|
|
from study enrollment (day 1) through study completion (approximately 2 years and 2 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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) |
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Lower than expected follow-up rates due to covid-19 restrictions
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santina Zanelli | University of Virginia Children's Hospital | 4349242697 | sz5d@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2024 | Sep 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2019 | Sep 30, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomized controlled trial
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| 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 |
|
| 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 |
| BG001 | Routine Care | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Primary | 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 | Posted | Number | percentage of participants | From discharge to 3 months follow-up |
|
|
|
| Primary | Adherence Rates | Adherence rates were monitored by daily activity logs of interventions from enrollment day 1 to discharge for each visit day | Posted | Number | percentage of participants | from study enrollment (day 1) to study discharge |
|
|
|
| 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); 3 months outcome reported. TIMP score range = 0-142; lower scores indicate worse motor performance | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
|
|
| 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, 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Primary | 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. | Abnormal general movements = absent fidgety classification | Posted | Number | percentage of participants | 3 months |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Routine Care | 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 | 1 | 34 | 0 | 34 | 0 | 34 |
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| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |