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NCT05568264 · ClinicalTrials.gov registry record · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
A NA study of Premature Birth and Bronchopulmonary Dysplasia, sponsored by Shirley Ryan AbilityLab.
- Recruiting
- Registry status
- NA
- Development phase
- 222
- Enrollment target
- 3
- Study locations
NCT05568264: Recruiting NA study of Premature Birth and Bronchopulmonary Dysplasia, sponsored by Shirley Ryan AbilityLab.
NCT05568264 is a NA study of Premature Birth and Bronchopulmonary Dysplasia that is actively recruiting participants, run by Shirley Ryan AbilityLab. The registered enrollment target is 222 participants, below the 388-participant average among 38 other Premature Birth trials with a reported enrollment target (43% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05568264, a NA study of Premature Birth and Bronchopulmonary Dysplasia, is actively recruiting participants, sponsored by Shirley Ryan AbilityLab.
- RECRUITING
- Registry status
- NA
- Development phase
- 222 participants
- Enrollment target
- 3
- Study locations
Study Summary
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. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
Primary Outcome
The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate
Conditions Studied
Interventions
- OTHER Physical Therapy intervention
Study Locations (3)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Northwestern Medicine Prentice Children's Hospital - Chicago
- Children's Hospital at the University of Illinois - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05568264 shows while recruiting
NCT05568264 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 388-participant average among 38 other Premature Birth trials with a reported enrollment target (43% lower).
The record links to 5 conditions, with Premature Birth appearing as the primary indexed condition, and to 1 intervention - of which Physical Therapy intervention is the first listed.
NCT05568264 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05568264 about?
NCT05568264 is a clinical study titled "Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit". 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...
What is the current status of trial NCT05568264?
This trial is currently recruiting. It is a NA study. The enrollment target is 222 participants. The study started on 2022-10-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05568264 study?
This clinical trial studies the following conditions: Premature Birth, Bronchopulmonary Dysplasia, Hypoxic Ischemic Encephalopathy, Intraventricular Hemorrhage, Motor Delay.
What interventions are being tested in trial NCT05568264?
The interventions under investigation include: Physical Therapy intervention (OTHER).
Who is sponsoring clinical trial NCT05568264?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05568264 being conducted?
This trial has 3 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05568264's enrollment target sits among peer trials
222 11th of 38 higher than 28 of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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