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Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease

NCT02781545 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2024-10-04

No results posted yet for this 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.

Conditions

  • Heart Defects, Congenital

Sponsors & Collaborators

  • Advocate Center for Pediatric Research

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Darlene Huisenga, PT, DPT, PCS · Wake Forest University Health Sciences

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781545 on ClinicalTrials.gov