Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
2 other identifiers
interventional
11
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedResults Posted
Study results publicly available
May 19, 2026
CompletedJune 26, 2026
June 1, 2026
2.2 years
November 9, 2021
July 25, 2025
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of the Neonatal Intensive Care Unit Component of the Intervention.
Feasibility will be defined as the proportion of infants 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 the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions.
6 months
Study Arms (2)
Usual Care
NO INTERVENTIONInfants 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.
Sensorimotor Intervention
EXPERIMENTALInfants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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. Only infants are considered enrolled in the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Hospital Los Angeles
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size. Some participants were lost to follow-up.
Results Point of Contact
- Title
- Stacey Dusing, PhD, PT, FAPTA
- Organization
- University of Southern California
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 23, 2021
Study Start
February 18, 2022
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
June 26, 2026
Results First Posted
May 19, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share