CompletedNot Applicable

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

United States11 participantsStarted 2022-02-18

Plain-language 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.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Only infants are considered enrolled in the study. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of the Neonatal Intensive Care Unit Component of the Intervention.

Timeframe: 2 weeks

Feasibility of the Entire Sensorimotor Intervention.

Timeframe: 6 months

Trial details

NCT IDNCT05130528

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

Results submitted2025-07-25

View on ClinicalTrials.gov More Cerebral Palsy trials

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.