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

This study is currently recruiting participants.
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

August 5, 2012
September 21, 2013
January 2012
March 2018   (final data collection date for primary outcome measure)
Presence of cerebral palsy [ Time Frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01659710 on ClinicalTrials.gov Archive Site
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Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients
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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Children's Memorial ICU Patients and Graduates

Medically Complex Infants
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  • 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).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
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March 2018   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
Yes
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United States
 
NCT01659710
2012-14808
No
Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: RayeAnn deRegnier, MD Lurie Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP