Health TrialsbyHealthPanel

Families Filming Infants Learning Movement

ConditionsInfant DevelopmentCerebral PalsyMotor DisordersNeurological Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-20
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Infants born full-term with typical development, bithweight >2500g

Infants with a history of brochopulmonary dysplasia, defined as having a preterm birth (<33 weeks gestational age) and requiring supplemental oxygen beyond 36 weeks gestational age

Infants with neonatal encephalopathy, who required hypothermic cooling treatment

Infants born <36 weeks gestational age

Disqualifiers

Children who are enrolled in DCFS custody

Parent or infant guardian does not have a smartphone

Trial population

Infants aged 10-20 weeks adjusted age. Not of other target special populations.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Observation of movement patterns through video recordings and neurodevelopmental battery of assessments.

Treatment groups

350 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Conrols - health term infants1 intervention
Group B: Bronchopulmonary dysplaspia1 intervention
Group C: Neonatal encephalopathy1 intervention
Group D: Congenital anomalies1 intervention
Group E: Preterm birth1 intervention
Group F: Multiple gestation1 intervention

Trial outcomes

Primary outcomes

1

Fidgety Movements in healthy, term born infants

Identify the timeframe in which fidgety movements are consistently present in healthy, term born infants

Time frame
4 months
2

Fidgety Movements in children with a range of medical complexities

Identify the time frame in which fidgety movements are consistently present in children with a range of medical complexities

Time frame
4 months
3

Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants

Identify the timeframe in which fidgety movements are most accurate in prediction of two-year neurodevelopmental outcomes in healthy, term born infants

Time frame
2 years
4

Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities

Identify the timeframe in which fidgety movements are most accurate in prediction of two-year neurodevelopmental outcomes in children with a range of medical complexities

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

Northwestern University

Sponsor institution

Northwestern University

Collaborator

IRCCS Fondazione Stella Maris

Collaborator

University of Melbourne

Collaborator

University of Sydney

Collaborator

Source ClinicalTrials.gov
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