Families Filming Infants Learning Movement

NCT06278961 | Recruiting

• 1 other identifier: IRB 2021-4329
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Development; Cerebral Palsy; Motor Disorders; Neurological Disorder

Keywords

fidgety movements; general movement assessment; cerebral palsy

Outcome Measures

Primary Outcomes (4)

• Fidgety Movements in healthy, term born infants

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

  4 months

• 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

  4 months

• 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

  2 years

• 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

  2 years

Study Arms (6)

Conrols - health term infants

Infants, less than 10 weeks of age at enrolment who were born full-term with typical development, birthweight \>2500g

Other: Observational

Bronchopulmonary dysplaspia

A history of bronchopulmonary dysplasia, defined as having a preterm birth (\<33 weeks' gestational age) and requiring supplemental oxygen beyond 36 weeks' gestational age

Other: Observational

Neonatal encephalopathy

term born infants who required hypothermic cooling treatment or had a diagnosis of hypoxic ischemic encephalopathy

Other: Observational

Congenital anomalies

Congenital anomalies of any kind eg cardiac, musculoskeletal, gastrointestinal

Other: Observational

Preterm birth

Preterm birth \<36 weeks gestational age

Other: Observational

Multiple gestation

One of a multiple gestation pregnancy

Other: Observational

Interventions

Observational OTHER

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

Bronchopulmonary dysplaspia; Congenital anomalies; Conrols - health term infants; Multiple gestation; Neonatal encephalopathy; Preterm birth

Eligibility Criteria

• Age: 10 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Infants born in a multiple gestation pregnancy
• Infants with a diagnosis of Trisomy 21
• Infants born and diagnosed with SMA prenatally, via newborn screening assessment or prior to 10 weeks corrected age
• Infants are less than 10 weeks corrected age at time of enrollment

You may not qualify if:

• Children who are enrolled in DCFS custody
• Parent or infant guardian does not have a smartphone

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University: collaborator
• IRCCS Fondazione Stella Maris: collaborator
• University of Melbourne: collaborator
• University of Sydney: collaborator

Study Sites (1)

Feinberg School of Physical Therapy and Human Movement Sciences

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Motor Disorders; Nervous System Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Imani Mann, B.S.

CONTACT

630-248-3514; imani.mann@northwestern.edu

Colleen Peyton, DPT

CONTACT

colleen.peyton1@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy and Human Movement Sciences and Pediatrics

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 28, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)