CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02781545
NCT02781545N/ACompleted

Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease

Wake Forest University Health Sciences·observational·Posted May 24, 2016·Updated Oct 4, 2024

In Brief

An observational study for Heart Defects, Congenital. Completed, enrolled 78 participants across 1 site.

Detailed Summary

Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 24, 2016
Enrollment StartMay 1, 2015
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.1 years ago