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