Clinical trial NCT05130528: Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Official title: Therapeutic Intervention Supporting Development From the Neonatal Intensive Care Unit to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hypoxic-Ischemic Encephalopathy
Keywords: infant
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-23
Enrollment: 12
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Hypoxic-ischemic encephalopathy (HIE) is a form of newborn brain injury resulting from a lack of oxygen or blood flow to the brain. Over 85 percent of infants with HIE now survive to discharge from the Neonatal Intensive Care Unit (NICU). Therapeutic hypothermia, now standard of care for HIE, improves survival, but does not decrease the incidence of moderate-severe disability or cerebral palsy. Therefore, infants with HIE may benefit from close developmental surveillance and a sensorimotor intervention that may induce positive neuroplasticity and optimize developmental outcomes. In addition, parents of infants with HIE may benefit from anticipatory guidance to promote global development and extensive education on how to monitor their infant for neurological signs and developmental delays that would warrant further medical and therapeutic assessments and services.

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. Twenty infants with moderate or severe HIE will be recruited and randomized into one of two groups: 1) standard care, and 2) standard care plus SMI. Infants in the SMI group will receive 2 intervention sessions in the NICU and 8 sessions in the home from 1 week to 6 months post discharge. The SMI will focus on supporting parents' ability to enhance motor-based problem solving and global development during the transition from NICU to home. Through this combined parent and therapist support intervention, the parents are empowered to provide their infants daily opportunities for sensorimotor play, increasing the likelihood of developmental change.

Outcomes will be measured at baseline, NICU discharge, and at 3 months and 6 months of age. Feasibility of enrolling, implementing the interventions, and completing the measurement model will be assessed. Secondary outcomes will include standardized assessments of motor and cognitive development of the infants and standardized assessments of confidence and stress of the parents. In addition, baseline neuroimaging data and the results of tests to detect cerebral palsy at 3 and 6 months of age will be used to characterize the participants and will be analyzed as potential moderators of treatment effects in future studies.

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.

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.

Primary outcomes:
measure: Feasibility of the Neonatal Intensive Care Unit component of the intervention.
timeFrame: 2 weeks
measure: Feasibility of the entire sensorimotor intervention.
timeFrame: 6 months
Secondary outcomes:
measure: Test of Infant Motor Performance (TIMP)
timeFrame: 3 months
measure: Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4): fine motor, gross motor and cognitive scaled scores
timeFrame: 6 months
measure: Sensory Profile 2 (SP2)
timeFrame: 3 months, 6 months
measure: Maternal Confidence Questionnaire (MCQ)
timeFrame: 3 months, 6 months
measure: Parent Stress Index - Short Form (PSI-sf)
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California / Children's Hospital Los Angeles
name: Stacey C Dusing, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Barbara Sargent, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: