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New treatment option for Motor Delay
Official title Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
ClinicalTrials.gov ID: NCT05568264
What this study is testing
- What it's testing
- Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 33 to 48
You may be able to join if
- NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW \<1500 grams OR
- Disorders of the central nervous system
- Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic...
- HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
You likely can't join if
- (related to inability to complete intervention, sensor placement, or clinic assessments)
- open wounds, skin condition precluding sensor placement
- immune deficiencies requiring protective isolation
- limb reduction defects
- followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- bleeding disorders or ongoing need for anticoagulation
See the full eligibility criteria
- NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- BW \<1500 grams OR
- Disorders of the central nervous system
- Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
- HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
- includes "at risk for HIE" with 10-minute Apgar \ /=12.
- Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
- Cramped synchronous movements at term PMA OR
- Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation. AND
- Medically stable AND able to start intervention between 34-48 weeks PMA.
- (related to inability to complete intervention, sensor placement, or clinic assessments)
- open wounds, skin condition precluding sensor placement
- immune deficiencies requiring protective isolation
- limb reduction defects
- followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- bleeding disorders or ongoing need for anticoagulation
- palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
- known visual impairment at the time of enrollment
- DCFS custody
- no English-speaking caregivers
- any other condition that would preclude participation in the study, as determined by the PI
- previously enrolled in competing assigned by chance trial with developmental outcome variables Each child's enrollment in the study will be approved by the child's neonatologist.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 33 weeks to 48 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.