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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01659710

Acronym

CIMA

Enrollment

208

Registered

2012-08-08

Start date

2012-01-31

Completion date

2019-01-31

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically Complex Infants

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results