CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled / 11 target
Drug / intervention
Sensorimotor Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05130528
NCT05130528N/ACompletedUpdate Overdue (0.2/mo)Completion was 26mo ago

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

University of Southern California·interventional·Posted Nov 23, 2021·Updated Jun 26, 2026

In Brief

A clinical study evaluating Sensorimotor Intervention for Cerebral Palsy and Hypoxic-Ischemic Encephalopathy. Completed, enrolled 11 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 23, 2021
Enrollment StartFeb 18, 2022
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.6 years ago

Arms & Interventions

Usual Careno_intervention

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.

Sensorimotor Interventionexperimental

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

Interventions

Sensorimotor Interventionbehavioral

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