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

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781545
• Other study ID #: AHC IRB#6036
• Status: Completed
• Start date: May 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2021
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Advocate Children's Hospital	Oak Lawn	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Advocate Health Care	Advocate Center for Pediatric Research, University Medical Center Groningen

Country where clinical trial is conducted

United States, 

References & Publications (7)

Brosig CL, Mussatto KA, Kuhn EM, Tweddell JS. Neurodevelopmental outcome in preschool survivors of complex congenital heart disease: implications for clinical practice. J Pediatr Health Care. 2007 Jan-Feb;21(1):3-12. — View Citation

Donofrio MT, Duplessis AJ, Limperopoulos C. Impact of congenital heart disease on fetal brain development and injury. Curr Opin Pediatr. 2011 Oct;23(5):502-11. doi: 10.1097/MOP.0b013e32834aa583. Review. — View Citation

Hadders-Algra M. General movements: A window for early identification of children at high risk for developmental disorders. J Pediatr. 2004 Aug;145(2 Suppl):S12-8. Review. — View Citation

Hadders-Algra M. Variation and variability: key words in human motor development. Phys Ther. 2010 Dec;90(12):1823-37. doi: 10.2522/ptj.20100006. Epub 2010 Oct 21. Review. — View Citation

Hamer EG, Bos AF, Hadders-Algra M. Assessment of specific characteristics of abnormal general movements: does it enhance the prediction of cerebral palsy? Dev Med Child Neurol. 2011 Aug;53(8):751-6. doi: 10.1111/j.1469-8749.2011.04007.x. Epub 2011 Jun 29. — View Citation

Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. Review. — View Citation

Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 months
Secondary	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	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
Secondary	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	18 months
Secondary	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)	18 months