Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 11 months
Healthy Volunteers: f
View:

⁃ 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 \<7 plus pH\<7.15 or base deficit \>/=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.

Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Children's Hospital at the University of Illinois
RECRUITING
Chicago
Northwestern Medicine Prentice Children's Hospital
RECRUITING
Chicago
Contact Information
Primary
Elizabeth Hoffman, DPT
ehoffman@sralab.org
312-238-7711
Backup
Sara Prokup, DPT
sprokup@sralab.org
312-238-1355
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 222
Treatments
Experimental: Physical Therapy Intervention
Infants enrolled in this arm will receive the intervention in addition to standard of care
No_intervention: Standard of Care
Infants enrolled in this arm will receive standard of care
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: Northwestern University, Northwestern Medicine, Ann & Robert H Lurie Children's Hospital of Chicago, University of Illinois at Chicago

This content was sourced from clinicaltrials.gov