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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Information provided by (Responsible Party):
Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01659710
First received: August 5, 2012
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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.


Condition
Medically Complex Infants

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Presence of cerebral palsy [ Time Frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: January 2012
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children's Memorial ICU Patients and Graduates

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659710

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Annamarie Hayner, M.Ed.    312-472-4338    ahayner@luriechildrens.org   
Principal Investigator: Raye Ann deRegnier, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: RayeAnn deRegnier, MD Lurie Children's Hospital
  More Information

No publications provided

Responsible Party: Raye Ann deRegnier, Associate Prof of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01659710     History of Changes
Other Study ID Numbers: 2012-14808
Study First Received: August 5, 2012
Last Updated: September 21, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014