Completed

NCT Number: NCT01659710

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

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.

Completed

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Key information

Conditions

Medically Complex Infants

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Presence of cerebral palsy

Time frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age

Sponsors and collaborators

Lead sponsor

Raye Ann deRegnier

Other

Registry information

Official study 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

Acronym: CIMA

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2019
First posted: Aug 8, 2012
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.