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

Primary Purpose

Cerebral Palsy, Hypoxic-Ischemic Encephalopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensorimotor Intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring infant

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Sensorimotor Intervention

Arm Description

Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.

Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Sensory Profile 2 (SP2)
Standardized questionnaire that assesses the infant's sensory system.
Maternal Confidence Questionnaire (MCQ)
Standardized questionnaire that assesses maternal confidence in parenting.
Parent Stress Index - Short Form (PSI-sf)
Standardized questionnaire that assesses the level of stress associated with the parenting role.

Full Information

First Posted
November 9, 2021
Last Updated
February 23, 2023
Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05130528
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Keywords
infant

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
Arm Title
Sensorimotor Intervention
Arm Type
Experimental
Arm Description
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
Intervention Type
Behavioral
Intervention Name(s)
Sensorimotor Intervention
Other Intervention Name(s)
Supporting and Enhancing NICU Sensory Experiences (SENSE), Supporting Play, Exploration, and Early Developmental Intervention (SPEEDI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of the Neonatal Intensive Care Unit component of the intervention.
Description
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.
Time Frame
2 weeks
Title
Feasibility of the entire sensorimotor intervention.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Test of Infant Motor Performance (TIMP)
Description
Standardized motor assessment for infants less than 4 months of age; raw scores will be used to document change over time.
Time Frame
3 months
Title
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4): fine motor, gross motor and cognitive scaled scores
Description
Standardized developmental assessment; scaled scores for the fine motor, gross motor, and cognitive subtests will be used to document change over time.
Time Frame
6 months
Title
Sensory Profile 2 (SP2)
Description
Standardized questionnaire that assesses the infant's sensory system.
Time Frame
3 months, 6 months
Title
Maternal Confidence Questionnaire (MCQ)
Description
Standardized questionnaire that assesses maternal confidence in parenting.
Time Frame
3 months, 6 months
Title
Parent Stress Index - Short Form (PSI-sf)
Description
Standardized questionnaire that assesses the level of stress associated with the parenting role.
Time Frame
3 months, 6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Sargent, PhD, PT
Phone
323-442-4823
Email
bsargent@pt.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey C Dusing, PhD, PT
Phone
323-442-1022
Email
stacey.dusing@pt.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey C Dusing, PhD, PT
Organizational Affiliation
University of Southern California / Children's Hospital Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Sargent, PhD, PT
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey C Dusing, PhD, PT
Phone
323-442-1022
Email
stacey.dusing@pt.usc.edu
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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