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NCT02781545 · ClinicalTrials.gov registry record
Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 78
- Enrollment target
NCT02781545: Completed study, sponsored by Wake Forest University Health Sciences.
NCT02781545 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 78 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02781545 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 78 participants
- Enrollment target
Study 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.
Primary Outcome
Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2015-05 |
| Est. Completion | 2019-06 |
What the finished NCT02781545 record still lists
NCT02781545 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 78 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02781545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02781545 about?
NCT02781545 is a clinical study titled "Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease". 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...
What is the current status of trial NCT02781545?
This trial is currently completed. The enrollment target is 78 participants. The study started on 2015-05. Estimated completion is 2019-06.
Who is sponsoring clinical trial NCT02781545?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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