NEO Rehab for Infants at Risk of Cerebral Palsy

NCT ID: NCT03372590

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-02
• Study Completion Date: 2019-06-30

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:

1. To determine the proportion of infants (<32 weeks gestation and/or <1500g) who have abnormal GMs findings using the GMA tool.

2. 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.

3. 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.

Conditions

Prematurity; Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NICU-based rehabilitation bundle

Intervention Type: OTHER

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

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.

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Standard NICU care

Interventions

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

Intervention Type: OTHER

Standard of care

Standard NICU care

Intervention Type: OTHER

Other Intervention Names

scent exchange; kangaroo care; massage; vocal soothing; comforting touch

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

• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Santina Zanelli

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santina A Zanelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

20318

Identifier Type: -

Identifier Source: org_study_id