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

This study is currently recruiting participants.
Verified August 2015 by Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659710
First Posted: August 8, 2012
Last Update Posted: August 13, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago
August 5, 2012
August 8, 2012
August 13, 2015
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 ]
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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
Sexes Eligible for Study: All
up to 5 Years   (Child)
Yes
United States
 
 
NCT01659710
2012-14808
No
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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
August 2015