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Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease (CHD-NIRS)

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ClinicalTrials.gov Identifier: NCT01679275
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Other: measuring cerebral oxygenation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
measuring cerebral oxygenation
NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease.
 Other: measuring cerebral oxygenation


Outcome Measures
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Primary Outcome Measures :
  1. Neurodevelopmental follow up at 24 months [ Time Frame: 24 months ]
    Neurodevelopmental assessment at 24 months using Bayley scales of infant development II


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neonates with admission on neonatal intensive care unit with congenital heart disease.

Exclusion Criteria:

  • No informed consent.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01679275


Contacts
Contact: Liesbeth Thewissen, MD +3216342569 liesbeth.thewissen@uzleuven.be

Locations
Belgium
Neonatal Intensive Care Unit UZLeuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Liesbeth Thewissen, MD    +3216342569    Liesbeth.thewissen@uzleuven.be   
Principal Investigator: Liesbeth Thewissen, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Liesbeth Thewissen, MD UZ Leuven
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01679275     History of Changes
Other Study ID Numbers: S54683
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Universitaire Ziekenhuizen Leuven:
Heart Defects, congenital
Patient Monitoring
Infant, Newborn
Physiology

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