An observational study in Heart Defects, Congenital, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Wake Forest University Health Sciences · Observational
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.
Congenital heart defects (CHD) are conditions present at birth and affect heart structure, function, and manner in which blood flows through the heart and to the rest of the body. The incidence of severe CHD is about 2.5 to 3/1,000 live births. With improvements in cardiac surgical technique and critical care medicine, the vast majority of babies with CHD are expected to survive to school age and beyond. However, these surgical and medical advances are also associated with increased risk for neurodevelopmental morbidity.
Traditionally, a quantitative approach measured gross motor development of infants at risk for delay, including children with complex congenital heart disease. These tools emphasize elicited responses; however, clinical use and validity may be limited by the infant's behavioral state, unstable physiological status, intolerance of handling, or sternal/surgical precautions. Alternatively, European clinicians working in the field of developmental neurology realized that variation and adaptability in motor behavior may assist in the evaluation of motor development. The application of motor variation and adaptability as a means to evaluate neuromotor condition in early infancy was significant for early detection of infants at high risk for developmental problems or cerebral palsy in a number of studies with high-risk infant groups. This form of evaluation has yet to be studied in infants with complex congenital heart diseases.
The proposed study aims to study motor development of two infant groups based on oxygen saturation targets after neonatal surgery and to study the validity of the assessment tools based on the quality of movement variation and adaptability, i.e., the General Movements Assessment (GMsA) and the Infant Motor Profile (IMP) in infants with complex congenital heart disease.
Hypothesis:
Baseline oxygen saturation after neonatal heart surgery in children with complex congenital heart diseases is a determinant of motor performance outcome at 18 months on the Infant Motor Profile.
Specific Objectives:
Specific Aims:
To explore the predictive value of GMsA at three months in a pooled group of infants with high oxygen saturation and low oxygen saturation with development outcome at 18 months assessed with:
To determine the concurrent validity of the Infant Motor Profile (IMP) on the basis of comparison with:
1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's enrollment of 78 is below the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Consecutive infant sampling of infants with complex congenital heart diseases
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Exclusion Criteria:
Motor development at 18 months
Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile
Time frame: 18 months
Movement quality from birth to 4 months of age
Comparison of the trajectory of movement quality for two infant groups based on video recorded General Movements Assessments for at least three assessment points from birth to 4 months of age
Time frame: 4 months. The infant's general movements are video-recorded three to five times from birth to four month according to this schedule: pre-operation (if possible), hospital discharge, one month of age, two months of age, and three months of age
Concurrent validity
Assess concurrent validity of the Infant Motor Profile total score and performance score with the Alberta Infant Motor Scales at 6, 12, and 18 months, and the Bayley Scales of Infant Development (3rd edition) motor composite score at 18 months
Time frame: 18 months
Cognitive and language development at 18 months
Comparison of the two infant groups based on the cognitive and language composite scores of the Bayley Scales of Infant Development (3rd edition)
Time frame: 18 months
Plan to share: Yes — Manuscript, Poster presentation, Conference presentation
Time frame: 6 months after publication
The record gives a start of May 2015, a primary completion of Jun 2019 and a completion of Jun 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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