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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Hypoxic-Ischemic Encephalopathy
• Intervention / Treatment: Behavioral: Sensorimotor Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Sargent, PhD, PT; Phone Number: 323-442-4823; Email: bsargent@pt.usc.edu
• Study Contact Backup: Name: Stacey C Dusing, PhD, PT; Phone Number: 323-442-1022; Email: stacey.dusing@pt.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Active, not recruiting
      • University of Southern California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Stacey C Dusing, PhD, PT; Phone Number: 323-442-1022; Email: stacey.dusing@pt.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants with moderate or severe hypoxic-ischemic encephalopathy (HIE) based on the modified Sarnat Exam on admission and has started to receive therapeutic hypothermia for 72 hours.
• Cared for in the Newborn and Infant Critical Care Unit (NICCU) at Children's Hospital Los Angeles (CHLA).
• Family lives within 60 miles of CHLA.
• One parent/legal guardian has provided signed and dated informed consent form agreeing to the child's participation and the parent's own participation.

Exclusion Criteria:

• Infant born preterm.
• Infant with congenital anomalies, chromosomal or microarray abnormalities.
• Infant with microcephaly.
• Infants who have been redirected for comfort care.
• Infants who are medically unstable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
Experimental: Sensorimotor Intervention; Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.	Behavioral: Sensorimotor Intervention; Infants in the experimental group will receive 2 sensorimotor intervention sessions in the Neonatal Intensive Care Unit (NICU) and 8 sensorimotor intervention sessions in the home or in a clinic (parent choice) at 1, 3, 5, 8, 11, 15, 20, 26 weeks post NICU discharge. The 2 intervention sessions in the NICU will consist of collaborating with parents to recognize their infant's cues to engage in interaction, readiness for sensory exposures, and anticipatory guidance on the transition to home. The 8 intervention sessions in the home will focus on supporting the parents to read their infant's cues to identify the ideal times for interaction and provide 20 minutes of daily intervention addressing four key principles: encourage 1) self-initiated movement, 2) movement variability, 3) visual and manual object interaction, and 4) social interaction. Parents are encouraged not to impose movement on the infant but to encourage movement through environmental enrichment; Other Names: Supporting and Enhancing NICU Sensory Experiences (SENSE); Supporting Play, Exploration, and Early Developmental Intervention (SPEEDI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Neonatal Intensive Care Unit component of the intervention.	Feasibility will be defined as the proportion of parent/infant dyads completing 2 assessments and 2 parent/therapist collaborative sensorimotor intervention sessions before Neonatal Intensive Care Unit discharge.	2 weeks
Feasibility of the entire sensorimotor intervention.	Feasibility will be defined as: (a) the proportion of parent/infant dyads completing 80% or more of the recommended 10 sensorimotor intervention sessions, and (b) the parents reporting daily completion of the sensorimotor intervention on 80% of randomly sampled days.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Infant Motor Performance (TIMP)	Standardized motor assessment for infants less than 4 months of age; raw scores will be used to document change over time.	3 months
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4): fine motor, gross motor and cognitive scaled scores	Standardized developmental assessment; scaled scores for the fine motor, gross motor, and cognitive subtests will be used to document change over time.	6 months
Sensory Profile 2 (SP2)	Standardized questionnaire that assesses the infant's sensory system.	3 months, 6 months
Maternal Confidence Questionnaire (MCQ)	Standardized questionnaire that assesses maternal confidence in parenting.	3 months, 6 months
Parent Stress Index - Short Form (PSI-sf)	Standardized questionnaire that assesses the level of stress associated with the parenting role.	3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Stacey C Dusing, PhD, PT, University of Southern California / Children's Hospital Los Angeles; Principal Investigator: Barbara Sargent, PhD, PT, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: infant
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Signs and Symptoms, Respiratory; Hypoxia, Brain; Cerebral Palsy; Brain Ischemia; Ischemia; Brain Diseases; Hypoxia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: CHLA-21-00290; P2CHD101912 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No