Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients (CIMA)

Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates

The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.

Study Overview

• Status: Unknown
• Conditions: Medically Complex Infants

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Annamarie Hayner, M.Ed.; Phone Number: 312-472-4338; Email: ahayner@luriechildrens.org
      • Principal Investigator: Raye Ann deRegnier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children's Memorial ICU Patients and Graduates

Description

Inclusion Criteria:

• Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
• Birth at <28 weeks gestation
• Birth weight <1000 grams
• Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
• Cardiac surgery during first 3 months of life
• Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age
• Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age)

Exclusion Criteria:

• Significant malformations/amputations of the extremities
• Recovering from a surgical procedure within 4 weeks of the assessment
• Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study Babies; Study video at 50-55 weeks gestational age, motor assessments at 24m (+/- 6 months) and again at 4 years (+/- 1 year).
Control Babies; Video at 50-55 weeks gestational age, motor assessment at 24 months (+/- 6 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of cerebral palsy	24 months (+/- 6 months) and 4 years (+/- 1 year) of age

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: RayeAnn deRegnier, MD, Lurie Children's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: August 5, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2012-14808