N/A N=11 Randomized Single-blind Other

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

Cerebral Palsy · Hypoxic-Ischemic Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT05130528 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. — 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sensorimotor Intervention (Behavioral)
Age: Pediatric
Sex: All
Sponsor: University of Southern California
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of the Neonatal Intensive Care Unit Component of the Intervention.	0; 1	—
PRIMARY Feasibility of the Entire Sensorimotor Intervention.	0; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05130528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.