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

NCT02781545 | Completed DMC

• 1 other identifier: AHC IRB#6036
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Child Development; Psychomotor Performance; Newborns; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Movement quality 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

• Concurrent validity

  18 months

• Cognitive and language development at 18 months

  18 months

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Consecutive infant sampling of infants with complex congenital heart diseases

You may qualify if:

• 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

You may not qualify if:

• Chromosomal abnormalities and/or known syndromes

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Advocate Center for Pediatric Research: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (7)

• 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.

  PMID: 21881507 BACKGROUND

• Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.

  PMID: 12084585 BACKGROUND

• 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. doi: 10.1016/j.pedhc.2006.03.008.

  PMID: 17198894 BACKGROUND

• 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. doi: 10.1067/mpd.2000.109152.

  PMID: 11060529 BACKGROUND

• 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.

  PMID: 20966209 BACKGROUND

• 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. doi: 10.1016/j.jpeds.2004.05.017.

  PMID: 15292882 BACKGROUND

• 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.

  PMID: 21711457 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Darlene Huisenga, PT, DPT, PCS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 24, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication

Locations

US (1)