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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659710
Recruitment Status : Unknown
Verified August 2015 by Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
First Posted : August 8, 2012
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):
Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:
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 or disease
Medically Complex Infants

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Study Type : Observational
Estimated Enrollment : 220 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : March 2018

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).

Primary Outcome Measures :
  1. Presence of cerebral palsy [ Time Frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children's Memorial ICU Patients and Graduates

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659710

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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   
Principal Investigator: Raye Ann deRegnier, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: RayeAnn deRegnier, MD Lurie Children's Hospital

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Responsible Party: Raye Ann deRegnier, Associate Prof of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago Identifier: NCT01659710    
Other Study ID Numbers: 2012-14808
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015