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Bronchopulmonary dysplaspia for Cerebral Palsy (FILM Trial)

N/A
Recruiting
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

FILM Trial Summary

The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.

Eligible Conditions
  • Cerebral Palsy
  • Infant Development
  • Motor Disorders
  • Neurological Disorders

FILM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities
Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants
Fidgety Movements in children with a range of medical complexities
+1 more

FILM Trial Design

6Treatment groups
Experimental Treatment
Group I: Preterm birthExperimental Treatment1 Intervention
Preterm birth <36 weeks gestational age
Group II: Neonatal encephalopathyExperimental Treatment1 Intervention
term born infants who required hypothermic cooling treatment or had a diagnosis of hypoxic ischemic encephalopathy
Group III: Multiple gestationExperimental Treatment1 Intervention
One of a multiple gestation pregnancy
Group IV: Conrols - health term infantsExperimental Treatment1 Intervention
Infants, less than 10 weeks of age at enrolment who were born full-term with typical development, birthweight >2500g
Group V: Congenital anomaliesExperimental Treatment1 Intervention
Congenital anomalies of any kind eg cardiac, musculoskeletal, gastrointestinal
Group VI: Bronchopulmonary dysplaspiaExperimental Treatment1 Intervention
A history of bronchopulmonary dysplasia, defined as having a preterm birth (<33 weeks' gestational age) and requiring supplemental oxygen beyond 36 weeks' gestational age

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,585 Previous Clinical Trials
916,881 Total Patients Enrolled
4 Trials studying Cerebral Palsy
179 Patients Enrolled for Cerebral Palsy
IRCCS Fondazione Stella MarisOTHER
39 Previous Clinical Trials
289,845 Total Patients Enrolled
15 Trials studying Cerebral Palsy
1,345 Patients Enrolled for Cerebral Palsy
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
256 Previous Clinical Trials
5,187,530 Total Patients Enrolled
1 Trials studying Cerebral Palsy
86 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Families Filming Infants Learning Movement
Colleen Peyton 2021. "Families Filming Infants Learning Movement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06278961.
All > Chicago > Milwaukee
~40 spots leftby Sep 2024
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