Cerebral PalsyNCT05130528
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
A study testing Sensorimotor Intervention in people with Cerebral Palsy and Hypoxic-Ischemic Encephalopathy, run by University of Southern California at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Sensorimotor Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Los Angeles
Los Angeles, California, 90033
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Therapeutic Intervention Supporting Development From the Neonatal Intensive Care Unit to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
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.
Read the 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.
- Conditions
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
- Being tested
- Sensorimotor Intervention
- Keywords
- infant
- Medical subject headings
- Cerebral Palsy, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor InterventionBehavioural
Also called Supporting and Enhancing NICU Sensory Experiences (SENSE), Supporting Play, Exploration, and Early Developmental Intervention (SPEEDI)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sensorimotor Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Feb 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Barbara Sargent, University of Southern California
- Investigators
- Stacey C Dusing, PhD, PT, Principal investigator, University of Southern California / Children's Hospital Los AngelesBarbara Sargent, PhD, PT, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130528
- Sponsor's protocol ID
- CHLA-21-00290
- Other IDs
- P2CHD101912
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2021
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Intervention Supporting Development From the Neonatal Intensive Care Unit to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT05130528
- Acronym / sponsor ID
- CHLA-21-00290
- Conditions
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
- Keywords
- infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Sensorimotor InterventionInfants 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorimotor InterventionAlso: Supporting and Enhancing NICU Sensory Experiences (SENSE), Supporting Play, Exploration, and Early Developmental Intervention (SPEEDI)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 | Behavioural | Sensorimotor Intervention |
Primary outcome
Feasibility of the Neonatal Intensive Care Unit Component of the Intervention.
Time frame: 2 weeks
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.
Feasibility of the Entire Sensorimotor Intervention.
Time frame: 6 months
Feasibility will be defined as the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey C Dusing, PhD, PT principal investigator
University of Southern California / Children's Hospital Los Angeles
Barbara Sargent, PhD, PT principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor Intervention in people with Cerebral Palsy and Hypoxic-Ischemic Encephalopathy, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.