NEO Rehab for Infants at Risk of Cerebral Palsy

NCT03372590 | Completed

• 1 other identifier: 20318
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Cerebral Palsy

Keywords

general movement assessment

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (2)

• Evolution of GMA patterns in high risk infants

  2 years

• Impact on maternal stress and depression

  2 years

Study Arms (2)

NICU-based rehabilitation bundle

EXPERIMENTAL

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

Standard of care

OTHER

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

Interventions

NICU-based rehabilitation bundle 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

Also known as: scent exchange, kangaroo care, massage, vocal soothing, comforting touch

NICU-based rehabilitation bundle

Standard of care OTHER

Standard NICU care

Standard of care

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Premature Birth; Cerebral Palsy

Interventions

Kangaroo-Mother Care Method; Massage; Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Santina A Zanelli, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: September 2, 2018
• Primary Completion: April 24, 2019
• Study Completion: June 30, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

US (1)