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

NCT05130528 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-19

Study results available
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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.

Conditions

  • Cerebral Palsy
  • Hypoxic-Ischemic Encephalopathy

Interventions

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Stacey C Dusing, PhD, PT · University of Southern California / Children's Hospital Los Angeles

  • Barbara Sargent, PhD, PT · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130528 on ClinicalTrials.gov