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

Completed

• Conditions: Medically Complex Infants

• Registration Number: NCT01659710
• Lead Sponsor: Raye Ann deRegnier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of cerebral palsy	24 months (+/- 6 months) and 4 years (+/- 1 year) of age

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States