NEO Rehab for Infants at Risk of Cerebral Palsy

Sponsor

University of Virginia (Other)

Overall Status

Completed

CT.gov ID

NCT03372590

Collaborator

(none)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity Cerebral Palsy	Other: NICU-based rehabilitation bundle Other: Standard of care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy

Actual Study Start Date :

Sep 2, 2018

Actual Primary Completion Date :

Apr 24, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NICU-based rehabilitation bundle 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.	Other: NICU-based rehabilitation bundle 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 Other Names: scent exchange kangaroo care massage vocal soothing comforting touch
Other: Standard of care 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.	Other: Standard of care Standard NICU care

Arm

Intervention/Treatment

Experimental: NICU-based rehabilitation bundle

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.

Other: NICU-based rehabilitation bundle

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

Other Names:

scent exchange

kangaroo care

massage

vocal soothing

comforting touch

Other: Standard of care

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.

Other: Standard of care

Standard NICU care

Outcome Measures

Primary Outcome Measures

NICU-based rehabilitation program feasibility [2 years]
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 [2 years]
GME will be scored on enrollment and at NICU discharge
Impact on maternal stress and depression [2 years]
Assessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 33 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

University of Virginia

Investigators

Principal Investigator: Santina A Zanelli, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Santina Zanelli, Associate Professor of Pediatrics, University of Virginia

ClinicalTrials.gov Identifier:

NCT03372590

Other Study ID Numbers:

20318

First Posted:

Dec 13, 2017

Last Update Posted:

Apr 3, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Santina Zanelli, Associate Professor of Pediatrics, University of Virginia

general movement assessment

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Apr 3, 2020