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NEO Rehab for Infants at Risk of Cerebral Palsy

Primary Purpose

Prematurity, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NICU-based rehabilitation bundle
Standard of care
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring general movement assessment

Eligibility Criteria

undefined - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infant Gestational age <32 weeks AND/OR birth weight <1500g

Exclusion Criteria:

  • Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline
  • Non-English-speaking mother
  • Mother is a prisoner
  • Confirmed inability to return for follow-up appointment

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NICU-based rehabilitation bundle

Standard of care

Arm Description

Patients identified to be at high risk for cerebral palsy will be enrolled after parental consent is obtained to the NICU rehabilitation program. This program consists of maternal-driven evidence based intervention that include: vocal soothing, scent exchange, comforting touch, kangaroo care, and infant massage. These intervention will be provided at GA-appropriate intervals.

Infants not participating in the intervention study will be provided with standard or care. Interventions include kangaroo care, physical therapy and infant massage provided by NICU staff.

Outcomes

Primary Outcome Measures

NICU-based rehabilitation program feasibility
The feasibility of a maternal driven intervention bundle will be assessed using a maternal diary and unannounced observations. The ability to perform the required intervention greater than 75% of the time will be considered successful

Secondary Outcome Measures

Evolution of GMA patterns in high risk infants
GME will be scored on enrollment and at NICU discharge
Impact on maternal stress and depression
Assessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument

Full Information

First Posted
December 8, 2017
Last Updated
April 2, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03372590
Brief Title
NEO Rehab for Infants at Risk of Cerebral Palsy
Official Title
NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool. Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants. This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.
Detailed Description
The study objective are 3-fold: To determine the proportion of infants (<32 weeks gestation and/or <1500g) who have abnormal GMs findings using the GMA tool. To determine the feasibility of NICU based rehabilitation program in 20 infants determined to be at high risk for CP using the GMA tool. The intervention bundle will consist of a maternal-driven gestational age (GA)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. Patients will be compared to contemporary and GA-matched controls receiving standard of care with a 1:2 assignment. To evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. Maternal stress will be measured using the Parental Stress Scale for NICU patients (PSS: NICU) prior to the intervention and prior to the infant's NICU discharge. Further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). Measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to NICU discharge using the Patient Reported Outcomes Measurement Information System (PROMIS) instrument. The investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Cerebral Palsy
Keywords
general movement assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICU-based rehabilitation bundle
Arm Type
Experimental
Arm Description
Patients identified to be at high risk for cerebral palsy will be enrolled after parental consent is obtained to the NICU rehabilitation program. This program consists of maternal-driven evidence based intervention that include: vocal soothing, scent exchange, comforting touch, kangaroo care, and infant massage. These intervention will be provided at GA-appropriate intervals.
Arm Title
Standard of care
Arm Type
Other
Arm Description
Infants not participating in the intervention study will be provided with standard or care. Interventions include kangaroo care, physical therapy and infant massage provided by NICU staff.
Intervention Type
Other
Intervention Name(s)
NICU-based rehabilitation bundle
Other Intervention Name(s)
scent exchange, kangaroo care, massage, vocal soothing, comforting touch
Intervention Description
Maternal-driven gestational age-appropriate intervention/activity bundle, including the evidence-based elements of vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard NICU care
Primary Outcome Measure Information:
Title
NICU-based rehabilitation program feasibility
Description
The feasibility of a maternal driven intervention bundle will be assessed using a maternal diary and unannounced observations. The ability to perform the required intervention greater than 75% of the time will be considered successful
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evolution of GMA patterns in high risk infants
Description
GME will be scored on enrollment and at NICU discharge
Time Frame
2 years
Title
Impact on maternal stress and depression
Description
Assessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infant Gestational age <32 weeks AND/OR birth weight <1500g Exclusion Criteria: Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline Non-English-speaking mother Mother is a prisoner Confirmed inability to return for follow-up appointment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santina A Zanelli, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

NEO Rehab for Infants at Risk of Cerebral Palsy

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