We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified May 2017 by Darlene Huisenga, Advocate Health Care
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781545
First Posted: May 24, 2016
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Advocate Center for Pediatric Research
University Medical Center Groningen
Information provided by (Responsible Party):
Darlene Huisenga, Advocate Health Care
  Purpose
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.

Condition
Heart Defects, Congenital

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Darlene Huisenga, Advocate Health Care:

Primary Outcome Measures:
  • Motor development at 18 months [ Time Frame: 18 months ]
    Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile


Secondary Outcome Measures:
  • Movement quality 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 ]
    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

  • Concurrent validity [ Time Frame: 18 months ]
    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

  • Cognitive and language development at 18 months [ Time Frame: 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)


Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive infant sampling of infants with complex congenital heart diseases
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781545


Contacts
Contact: Darlene Huisenga, PT, DPT, PCS 708.684.1365 darlene.huisenga@advocatehealth.com
Contact: Andrew Van Bergen, MD 708.684.5580 andrew.vanbergen@advocatehealth.com

Locations
United States, Illinois
Advocate Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Darlene Huisenga, PT, DPT, PCS    708-684-1365    darlene.huisenga@advocatehealth.com   
Contact: Andrew Van Bergen, MD    708.684.5580    andrew.vanbergen@advocatehealth.com   
Sponsors and Collaborators
Advocate Health Care
Advocate Center for Pediatric Research
University Medical Center Groningen
Investigators
Principal Investigator: Darlene Huisenga, PT, DPT, PCS Advocate Health Care
  More Information

Publications:
Responsible Party: Darlene Huisenga, PT, DPT, PCS, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02781545     History of Changes
Other Study ID Numbers: AHC IRB#6036
First Submitted: May 18, 2016
First Posted: May 24, 2016
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Manuscript, Poster presentation, Conference presentation

Keywords provided by Darlene Huisenga, Advocate Health Care:
Child Development
Psychomotor Performance
Newborns
Surgery

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities