Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy

Cerebral Palsy Clinical Trial

Official title: Therapeutic Intervention Supporting Development From the Neonatal Intensive Care Unit to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.

Clinical Trial Description

Hypoxic-ischemic encephalopathy (HIE) is a form of newborn brain injury resulting from a lack of oxygen or blood flow to the brain. Over 85 percent of infants with HIE now survive to discharge from the Neonatal Intensive Care Unit (NICU). Therapeutic hypothermia, now standard of care for HIE, improves survival, but does not decrease the incidence of moderate-severe disability or cerebral palsy. Therefore, infants with HIE may benefit from close developmental surveillance and a sensorimotor intervention that may induce positive neuroplasticity and optimize developmental outcomes. In addition, parents of infants with HIE may benefit from anticipatory guidance to promote global development and extensive education on how to monitor their infant for neurological signs and developmental delays that would warrant further medical and therapeutic assessments and services.

The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life. Twenty infants with moderate or severe HIE will be recruited and randomized into one of two groups: 1) standard care, and 2) standard care plus SMI. Infants in the SMI group will receive 2 intervention sessions in the NICU and 8 sessions in the home from 1 week to 6 months post discharge. The SMI will focus on supporting parents' ability to enhance motor-based problem solving and global development during the transition from NICU to home. Through this combined parent and therapist support intervention, the parents are empowered to provide their infants daily opportunities for sensorimotor play, increasing the likelihood of developmental change.

Outcomes will be measured at baseline, NICU discharge, and at 3 months and 6 months of age. Feasibility of enrolling, implementing the interventions, and completing the measurement model will be assessed. Secondary outcomes will include standardized assessments of motor and cognitive development of the infants and standardized assessments of confidence and stress of the parents. In addition, baseline neuroimaging data and the results of tests to detect cerebral palsy at 3 and 6 months of age will be used to characterize the participants and will be analyzed as potential moderators of treatment effects in future studies. ;

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cerebral Palsy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

• NCT number: NCT05130528
• Study type: Interventional
• Source: University of Southern California
• Contact: Barbara Sargent, PhD, PT
• Phone: 323-442-4823
• Email: bsargent@pt.usc.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Completion date: April 30, 2024