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Completed NCT05130528

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

Conditions: Cerebral Palsy, Hypoxic-Ischemic Encephalopathy

Sex: All
Ages: N/A – 6 Months
Healthy volunteers: No
Phase: NA
Enrollment: 11
Sponsor: University of Southern California

Location: Children's Hospital Los Angeles Los Angeles California

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05130528). StuddyBuddy aggregates publicly available trial information.