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

Raye Ann deRegnier

Status: Completed

Conditions: Medically Complex Infants

Study type: Observational

Funder types: Other

Identifiers

NCT01659710

2012-14808

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

208 participants in 2 patient groups

Study Babies

Description:

Study video at 50-55 weeks gestational age, motor assessments at 24m (+/- 6 months) and again at 4 years (+/- 1 year).

Control Babies

Description:

Video at 50-55 weeks gestational age, motor assessment at 24 months (+/- 6 months).