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| ID | Type | Description | Link |
|---|---|---|---|
| P2CHD101912 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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. | |
| Sensorimotor Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensorimotor Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. | Feasibility will be defined as the proportion of infants completing 2 assessments and 2 parent/therapist collaborative sensorimotor intervention sessions before Neonatal Intensive Care Unit discharge. | 2 weeks |
| Feasibility of the Entire Sensorimotor Intervention. | Feasibility will be defined as the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey C Dusing, PhD, PT | University of Southern California / Children's Hospital Los Angeles | Principal Investigator |
| Barbara Sargent, PhD, PT | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90033 | United States | ||
| University of Southern California |
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11 infants recruited into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 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. |
| FG001 | Sensorimotor Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 |
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| Los Angeles |
| California |
| 90033 |
| United States |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | 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. |
| BG001 | Sensorimotor Intervention | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | Participants |
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| Diagnosis of hypoxic-ischemic encephalopathy | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. | Feasibility will be defined as the proportion of infants completing 2 assessments and 2 parent/therapist collaborative sensorimotor intervention sessions before Neonatal Intensive Care Unit discharge. | Posted | Count of Participants | Participants | 2 weeks |
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| Primary | Feasibility of the Entire Sensorimotor Intervention. | Feasibility will be defined as the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions. | Posted | Count of Participants | Participants | 6 months |
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2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Sensorimotor Intervention | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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Small sample size. Some participants were lost to follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Dusing, PhD, PT, FAPTA | University of Southern California | (323) 442-0191 | stacey-dusing@pt.usc.edu |
| Jul 25, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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