Trial record 11 of 844 for:    "Heart Defects, Congenital"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: August 31, 2012
Last updated: December 7, 2015
Last verified: December 2015
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 Intervention
Heart Defects, Congenital
Other: measuring cerebral oxygenation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Neurodevelopmental follow up at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

Estimated Enrollment: 75
Study Start Date: October 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01679275

Contact: Liesbeth Thewissen, MD +3216342569

Neonatal Intensive Care Unit UZLeuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Liesbeth Thewissen, MD    +3216342569   
Principal Investigator: Liesbeth Thewissen, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Liesbeth Thewissen, MD UZ Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01679275     History of Changes
Other Study ID Numbers: S54683 
Study First Received: August 31, 2012
Last Updated: December 7, 2015
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases processed this record on May 26, 2016