Motor DelayNCT05251051
Project Initiate: Transition to Community Therapy Services After NICU Discharge
A study testing pediatric physical therapy and Care Coordination in people with Motor Delay, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.
Trial summary
Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Motor Delay
- What is being tested?
- pediatric physical therapy and Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Feb 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At-risk for developmental impairments (enrolled in Early Childhood Clinic and are automatically eligible for Illinois Early Intervention services)
- Less that 45 weeks post-menstrual age (PMA) at discharge
- English-speaking
- Able to be identified and enrolled before discharge from the NICU
Who cannot join
- Children in DCFS custody or children of parents who decline therapy services through the State of Illinois Early Intervention Program.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Illinois at Chicago
Chicago, Illinois, 60607
Lurie Children's Hospital
Chicago, Illinois, 60611
Prentice Women's Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Project INITIATE: Developing Community Collaborations to Improve Developmental Outcomes Through Prompt and Equitable Transition to Community Therapy Services in High-risk Newborn Infants
Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
Read the detailed description
Infants hospitalized in an neonatal intensive care unit with high risk illnesses typically receive physical therapy during the hospital stay to improve neuromotor function and promote optimal development. At discharge, infants residing in Illinois with high risk conditions are eligible for therapy services in the home through Illinois Early Intervention. The initiation of these services is typically delayed for several months or more after discharge and families with private insurance will often obtain transitional services. For children with Medicaid insurance, initiation of services is typically delayed or never occurs and there is concern that gaps in services may worsen outcomes and cause stress to parents.
The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
The aims of Project Initiate are:
Specific Aim 1: To pilot a NICU to home service delivery model for infants at high-risk for neuromotor complications with Medicaid Insurance.
Specific Aim 2: To test the feasibility of at NICU to home service delivery model for infants at high-risk for neuromotor complications.
Specific Aim 3: To compare motor and parental quality of life outcomes at 3-4 months corrected age in study participants and those who received standard discharge services.
Families of infants with high risk medical conditions qualifying for Early Intervention services will be recruited at NICU discharge and assigned to the intervention or control group based on the parents' city of residence (based on the availability of home therapists by location).
For the intervention group, therapy will be provided weekly within two weeks of discharge. Infants will be enrolled in Early Intervention, infants will receive care coordination to assist in engagement with the Early Intervention program and home services will be provided through the study until the Early intervention services are fully engaged or for 14 weeks, whichever comes first.
For the control group, infants will be enrolled in Early Intervention and infants will receive care coordination to assist in engagement with the Early Intervention program. If transitional services are recommended at discharge, the therapy care coordinator will assist families with these referrals until Early intervention is fully engaged r for 14 weeks, whichever comes first.
At discharge, neuromotor outcomes will be assessed. At 3 months corrected age, all infants will be evaluated in the Early Childhood clinic and their neuromotor outcome will be assessed. Parents will also complete quality of life surveys at discharge and at 3 months corrected age.
- Conditions
- Motor Delay
- Being tested
- pediatric physical therapy, Care Coordination
- Medical subject headings
- Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric physical therapyBehavioural
Pediatric physical therapists will provide weekly home therapy using standard of care/best evidence procedures
Care CoordinationOther
Also called Navigation
A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements.
At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge. Receives: Behavioral: pediatric physical therapy; Other: Care Coordination |
| Control Group | Other | At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. If transitional services were recommended by the NICU providers, the navigator will help families identify these services and obtain the necessary referrals. Receives: Other: Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Performance Score (TIMP)
The TIMP is a motor evaluation conducted by a physical therapist. The test is scored and the scores are converted to standard deviations based on the child's age. Changes in the infant's TIMP standard deviation score from discharge to 3 months of age, corrected for prematurity, assessed by an physical therapist blinded to the intervention group.
Measured: 2-3 months (discharge to first developmental clinic visit)
Time to initiation of Early Intervention therapy services
The time from discharge to the first Early Intervention home therapy service will be assessed
Measured: Discharge to EI initiation (1-6 months)
Parent quality of life questionnaire assessed using the Peds QL Family Impact Module
Parent quality of life will be assessed at the beginning and end of the study. This test asks parents to rate their quality of life in 6 categories. Each item is scored on a Likert Scale from 0-4 and then reverse transformed to a score from 0-100. The investigators will use an overall score averaged from the 6 categories as an outcome, as well as scores for the individual categories. Higher scores indicated better parent reported quality of life.
Measured: 2-3 months
Secondary outcomes (2)
General movements assessment-
Motor optimality scores will be obtained from observation of standard videos and rated by blinded trained observers. Motor optimality scores can range from 5-28 with higher scores indicating better motor optimality.
Measured: At 3 months corrected age
Hammersmith Infant Neurologic examination
A neurologic examination performed by blinded observers who have been trained (physical therapists or physicians). Each item (n=26) is scored from 0-3 points. Higher scores indicate better neurologic function with a maximum score of 78.
Measured: At 3 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start23 Feb 2022
- Primary completion27 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DelayStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be assigned to an intervention or control group based on the city of residence at discharge (Chicago or not-Chicago)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, University of Chicago
- Responsible party
- Principal investigator, Raye Ann deRegnier, Northwestern University
- Investigators
- Raye-Ann deRegnier, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251051
- Sponsor's protocol ID
- 2021-4541
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project INITIATE: Developing Community Collaborations to Improve Developmental Outcomes Through Prompt and Equitable Transition to Community Therapy Services in High-risk Newborn Infants
- ClinicalTrials.gov ID
- NCT05251051
- Acronym / sponsor ID
- 2021-4541
- Conditions
- Motor Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of Chicago
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
Detailed description
Infants hospitalized in an neonatal intensive care unit with high risk illnesses typically receive physical therapy during the hospital stay to improve neuromotor function and promote optimal development. At discharge, infants residing in Illinois with high risk conditions are eligible for therapy services in the home through Illinois Early Intervention. The initiation of these services is typically delayed for several months or more after discharge and families with private insurance will often obtain transitional services. For children with Medicaid insurance, initiation of services is typically delayed or never occurs and there is concern that gaps in services may worsen outcomes and cause stress to parents.
The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
The aims of Project Initiate are:
Specific Aim 1: To pilot a NICU to home service delivery model for infants at high-risk for neuromotor complications with Medicaid Insurance.
Specific Aim 2: To test the feasibility of at NICU to home service delivery model for infants at high-risk for neuromotor complications.
Specific Aim 3: To compare motor and parental quality of life outcomes at 3-4 months corrected age in study participants and those who received standard discharge services.
Families of infants with high risk medical conditions qualifying for Early Intervention services will be recruited at NICU discharge and assigned to the intervention or control group based on the parents' city of residence (based on the availability of home therapists by location).
For the intervention group, therapy will be provided weekly within two weeks of discharge. Infants will be enrolled in Early Intervention, infants will receive care coordination to assist in engagement with the Early Intervention program and home services will be provided through the study until the Early intervention services are fully engaged or for 14 weeks, whichever comes first.
For the control group, infants will be enrolled in Early Intervention and infants will receive care coordination to assist in engagement with the Early Intervention program. If transitional services are recommended at discharge, the therapy care coordinator will assist families with these referrals until Early intervention is fully engaged r for 14 weeks, whichever comes first.
At discharge, neuromotor outcomes will be assessed. At 3 months corrected age, all infants will be evaluated in the Early Childhood clinic and their neuromotor outcome will be assessed. Parents will also complete quality of life surveys at discharge and at 3 months corrected age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Infants will be assigned to an intervention or control group based on the city of residence at discharge (Chicago or not-Chicago)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: pediatric physical therapy, Other: Care CoordinationAt NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge. |
| Control Group | Other | Other: Care CoordinationAt NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. If transitional services were recommended by the NICU providers, the navigator will help families identify these services and obtain the necessary referrals. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At-risk for developmental impairments (enrolled in Early Childhood Clinic and are automatically eligible for Illinois Early Intervention services)
- Less that 45 weeks post-menstrual age (PMA) at discharge
- English-speaking
- Able to be identified and enrolled before discharge from the NICU
Key exclusion criteria (1 listed)
- Children in DCFS custody or children of parents who decline therapy services through the State of Illinois Early Intervention Program.
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 |
|---|---|---|
| pediatric physical therapyPediatric physical therapists will provide weekly home therapy using standard of care/best evidence procedures | Behavioural | Intervention Group |
| Care CoordinationAlso: NavigationA navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed | Other | Control Group, Intervention Group |
Primary outcome
Test of Infant Motor Performance Score (TIMP)
Time frame: 2-3 months (discharge to first developmental clinic visit)
The TIMP is a motor evaluation conducted by a physical therapist. The test is scored and the scores are converted to standard deviations based on the child's age. Changes in the infant's TIMP standard deviation score from discharge to 3 months of age, corrected for prematurity, assessed by an physical therapist blinded to the intervention group.
Time to initiation of Early Intervention therapy services
Time frame: Discharge to EI initiation (1-6 months)
The time from discharge to the first Early Intervention home therapy service will be assessed
Parent quality of life questionnaire assessed using the Peds QL Family Impact Module
Time frame: 2-3 months
Parent quality of life will be assessed at the beginning and end of the study. This test asks parents to rate their quality of life in 6 categories. Each item is scored on a Likert Scale from 0-4 and then reverse transformed to a score from 0-100. The investigators will use an overall score averaged from the 6 categories as an outcome, as well as scores for the individual categories. Higher scores indicated better parent reported quality of life.
2 secondary outcomes
General movements assessment-
Time frame: At 3 months corrected age
Hammersmith Infant Neurologic examination
Time frame: At 3 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- 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.
Raye-Ann deRegnier, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pediatric physical therapy and Care Coordination in people with Motor Delay, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 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 1 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Test of Infant Motor Performance Score (TIMP) (time frame: 2-3 months (discharge to first developmental clinic visit)). The study lists 3 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 13 Dec 2024.