Early Detection for Cerebral Palsy
(FILM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to enhance the early detection of neurodevelopmental impairments, such as cerebral palsy (CP), by identifying the optimal timing for a specific movement assessment. Researchers are studying both healthy infants and those at risk for CP. The trial will include 350 infants, divided into groups based on factors like premature birth or certain medical conditions. Infants less than 10 weeks old, whether born full-term and healthy or with conditions like preterm birth or congenital anomalies, may be suitable for this study.
As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could improve early detection methods for neurodevelopmental impairments.
What prior data suggests that the Prechtl GMA is safe for early detection of neurodevelopmental impairment?
Research has shown that treatments for bronchopulmonary dysplasia (BPD) and neonatal encephalopathy have been studied for safety in various settings. For infants with BPD, studies indicate that up to 50% are readmitted to the hospital due to breathing problems in their first year. While BPD itself is challenging, researchers carefully monitor the treatments for safety.
For neonatal encephalopathy, cooling the body, known as therapeutic hypothermia, has proven safe and effective. It reduces the risk of death and disability in infants with moderate to severe cases by protecting the brain after a lack of oxygen at birth.
Both treatments have been used before and are supported by research, but all medical treatments carry some risks. Participants should discuss any concerns with their healthcare provider to understand how these treatments might affect them or their infants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how infants learn movement, especially in those with conditions like bronchopulmonary dysplasia, preterm birth, and congenital anomalies. Unlike most studies that focus on medical interventions, this trial uses a novel approach by involving families in filming their infants. This method could provide unique insights into early movement development and help tailor future therapeutic strategies. By understanding these patterns, researchers hope to develop more personalized and effective interventions for infants with diverse developmental challenges.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Families film infants using the Baby Moves app at specified time points (10, 12, 14, 16, 18, and 20 weeks of corrected age). Videos are uploaded for assessment.
Follow-up
Participants are monitored for neurodevelopmental outcomes at 1 and 2 years of age, including standardized assessments and questionnaires.
Long-term Follow-up
Infants are followed for 5 years to monitor neurodevelopmental outcomes, with data collected from follow-up clinics and surveys.
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Preterm birth \<36 weeks gestational age
term born infants who required hypothermic cooling treatment or had a diagnosis of hypoxic ischemic encephalopathy
One of a multiple gestation pregnancy
Infants, less than 10 weeks of age at enrolment who were born full-term with typical development, birthweight \>2500g
Congenital anomalies of any kind eg cardiac, musculoskeletal, gastrointestinal
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 Clinic Near You
Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
Northwestern University
Collaborator
IRCCS Fondazione Stella Maris
Collaborator
University of Sydney
Collaborator
University of Melbourne
Collaborator
Citations
Lifetime patient outcomes and healthcare utilization for ...
We developed a microsimulation model to estimate lifetime clinical and economic burden of BPD among extreme preterm infants (≤28 weeks gestational age at birth) ...
2.
publications.aap.org
publications.aap.org/pediatrics/article/156/5/e2025070741/204577/Prognostic-Accuracy-of-BPD-Definitions-for-LongPrognostic Accuracy of BPD Definitions for Long-Term ...
The 2001 NIH definition showed higher prognostic accuracy for respiratory and neurological outcomes compared with the 1988 Shennan BPD ...
Outcomes of extremely preterm infants with ...
Up to 50% of infants with BPD experience high readmission rates due to lower respiratory tract infections in the first year. A recent study ...
Rates of Bronchopulmonary Dysplasia Following ...
This quality improvement study assesses whether a consistent, systematic prevention system of care decreases the rate of bronchopulmonary ...
Respiratory management and outcomes in high-risk ... - Thorax
Over the study period, mortality decreased (10.1%–8.5%), with increases in BPD (28%–33%), severe BPD (12%–17%), composite BPD/death (35%–39%) and composite ...
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