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

Cerebral Palsy Clinical Trial

Official title:

Therapeutic Intervention Supporting Development From the Neonatal Intensive Care Unit to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130528
• Other study ID #: CHLA-21-00290
• Secondary ID: P2CHD101912
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: Barbara Sargent, PhD, PT
• Phone: 323-442-4823
• Email: bsargent[@]pt.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cerebral Palsy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Behavioral:
• Sensorimotor Intervention
Infants in the experimental group will receive 2 sensorimotor intervention sessions in the Neonatal Intensive Care Unit (NICU) and 8 sensorimotor intervention sessions in the home or in a clinic (parent choice) at 1, 3, 5, 8, 11, 15, 20, 26 weeks post NICU discharge. The 2 intervention sessions in the NICU will consist of collaborating with parents to recognize their infant's cues to engage in interaction, readiness for sensory exposures, and anticipatory guidance on the transition to home. The 8 intervention sessions in the home will focus on supporting the parents to read their infant's cues to identify the ideal times for interaction and provide 20 minutes of daily intervention addressing four key principles: encourage 1) self-initiated movement, 2) movement variability, 3) visual and manual object interaction, and 4) social interaction. Parents are encouraged not to impose movement on the infant but to encourage movement through environmental enrichment

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Neonatal Intensive Care Unit component of the intervention.	Feasibility will be defined as the proportion of parent/infant dyads completing 2 assessments and 2 parent/therapist collaborative sensorimotor intervention sessions before Neonatal Intensive Care Unit discharge.	2 weeks
Primary	Feasibility of the entire sensorimotor intervention.	Feasibility will be defined as: (a) the proportion of parent/infant dyads completing 80% or more of the recommended 10 sensorimotor intervention sessions, and (b) the parents reporting daily completion of the sensorimotor intervention on 80% of randomly sampled days.	6 months
Secondary	Test of Infant Motor Performance (TIMP)	Standardized motor assessment for infants less than 4 months of age; raw scores will be used to document change over time.	3 months
Secondary	Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4): fine motor, gross motor and cognitive scaled scores	Standardized developmental assessment; scaled scores for the fine motor, gross motor, and cognitive subtests will be used to document change over time.	6 months
Secondary	Sensory Profile 2 (SP2)	Standardized questionnaire that assesses the infant's sensory system.	3 months, 6 months
Secondary	Maternal Confidence Questionnaire (MCQ)	Standardized questionnaire that assesses maternal confidence in parenting.	3 months, 6 months
Secondary	Parent Stress Index - Short Form (PSI-sf)	Standardized questionnaire that assesses the level of stress associated with the parenting role.	3 months, 6 months