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Behavioral Intervention

Sensorimotor Intervention for Brain Injury

N/A
Recruiting
Led By Barbara Sargent, PhD, PT
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights

Study Summary

This trial will test whether an early intervention can improve outcomes for infants with hypoxic-ischemic encephalopathy.

Who is the study for?
This trial is for infants with moderate or severe hypoxic-ischemic encephalopathy who are receiving care at CHLA and have undergone therapeutic hypothermia. Families must live within 60 miles of CHLA, and a parent must consent to participate. Infants with microcephaly, preterm birth, congenital anomalies, or instability are excluded.Check my eligibility
What is being tested?
The study tests a sensorimotor intervention (SMI) provided during the first six months of life for infants affected by hypoxic-ischemic encephalopathy to assess its feasibility and potential effects on development.See study design
What are the potential side effects?
As this trial involves non-pharmaceutical therapy focusing on infant development support through sensorimotor activities, specific side effects are not detailed but will be monitored for any adverse reactions related to the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant has severe brain damage from lack of oxygen and is receiving cooling treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the Neonatal Intensive Care Unit component of the intervention.
Feasibility of the entire sensorimotor intervention.
Secondary outcome measures
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4): fine motor, gross motor and cognitive scaled scores
Maternal Confidence Questionnaire (MCQ)
Parent Stress Index - Short Form (PSI-sf)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sensorimotor InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
900 Previous Clinical Trials
1,595,603 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,682 Previous Clinical Trials
6,930,786 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,460 Total Patients Enrolled

Media Library

Sensorimotor Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05130528 — N/A
Hypoxic-Ischemic Encephalopathy Research Study Groups: Usual Care, Sensorimotor Intervention
Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Sensorimotor Intervention Highlights & Side Effects. Trial Name: NCT05130528 — N/A
Sensorimotor Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130528 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being utilized in this research project?

"Affirmative. The clinicaltrials.gov page reveals that this trial, published on February 18th 2022 and last modified on February 24th 2022 is recruiting participants. 20 people need to be recruited from one medical centre."

Answered by AI

Is enrollment to this research still available?

"Clinicaltrials.gov affirms that this medical experiment is actively recruiting patients. It was initially published on February 18th 2022 and subsequently revised four days later."

Answered by AI

What aims is this trial trying to accomplish?

"This clinical trial, which will span two weeks in duration, seeks to determine the practicality of a sensorimotor intervention. Secondary endpoints include Bayley Scales of Infant and Toddler Development (Bayley-4), Maternal Confidence Questionnaire (MCQ) as well as Parent Stress Index - Short Form (PSI-sf)."

Answered by AI
~1 spots leftby Apr 2024