N/A
Completed N=11
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Source: ClinicalTrials.gov NCT05130528 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. — 0; 1 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.