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

Completed · Not applicable

Conditions studied: Cerebral Palsy, Hypoxic-Ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT05130528

Run by

University of Southern California

People needed

11

Starts

2022-02-18

Expected to finish

2024-04-30

Last updated by the study team

2026-06-26

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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