Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/6/2018 |
| Start Date: | May 2015 |
| End Date: | June 2019 |
Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates 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 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.
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:
1. To determine developmental outcomes at 18 months in two infant groups based on oxygen
saturation targets.
2. To validate specific neuromotor assessment tools that determine developmental outcome in
two infant groups based on oxygen saturation targets.
Specific Aims:
1. To compare motor outcomes at 18 months measured with the IMP of two groups of infants
who had surgery as neonates for complex congenital heart disease grouped by baseline
oxygen saturation targets after the first surgery (≥ 90%; high saturation and < 90%; low
saturation, i.e., admixed lesions).
2. To describe the quality of general movements from birth through three months at five
assessment points in infants with high oxygen saturation and infants with low oxygen
saturation.
3. To describe motor development in terms of IMP-scores at 6, 12 and 18 months in infants
with high oxygen saturation and infants with low oxygen saturation.
4. 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:
1. Infant Motor Profile (IMP)
2. Alberta Infant Motor Scales (AIMS)
3. Motor Composite score of the Bayley Scales of Infant Development, 3rd edition
(BSID-3)
4. Cognitive and Language composite scores of the BSID-3.
5. To determine the concurrent validity of the Infant Motor Profile (IMP) on the basis of
comparison with:
1. Alberta Infant Motor Scales (AIMS) at 6, 12, and 18 months.
2. Bayley Motor Composite score at 18 months.
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:
1. To determine developmental outcomes at 18 months in two infant groups based on oxygen
saturation targets.
2. To validate specific neuromotor assessment tools that determine developmental outcome in
two infant groups based on oxygen saturation targets.
Specific Aims:
1. To compare motor outcomes at 18 months measured with the IMP of two groups of infants
who had surgery as neonates for complex congenital heart disease grouped by baseline
oxygen saturation targets after the first surgery (≥ 90%; high saturation and < 90%; low
saturation, i.e., admixed lesions).
2. To describe the quality of general movements from birth through three months at five
assessment points in infants with high oxygen saturation and infants with low oxygen
saturation.
3. To describe motor development in terms of IMP-scores at 6, 12 and 18 months in infants
with high oxygen saturation and infants with low oxygen saturation.
4. 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:
1. Infant Motor Profile (IMP)
2. Alberta Infant Motor Scales (AIMS)
3. Motor Composite score of the Bayley Scales of Infant Development, 3rd edition
(BSID-3)
4. Cognitive and Language composite scores of the BSID-3.
5. To determine the concurrent validity of the Infant Motor Profile (IMP) on the basis of
comparison with:
1. Alberta Infant Motor Scales (AIMS) at 6, 12, and 18 months.
2. Bayley Motor Composite score at 18 months.
Inclusion Criteria:
- Infants diagnosed with complex congenital heart diseases that require surgery during
the neonatal period, ages 0-30 days
- Surgical care at Advocate Christ Medical Center/Advocate Children's Hospital, Oak
Lawn, Il
Exclusion Criteria:
- Chromosomal abnormalities and/or known syndromes
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