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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Defects, Congenital | Other: measuring cerebral oxygenation | Not Applicable |
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 |
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.
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Other: measuring cerebral oxygenation |
- Neurodevelopmental follow up at 24 months [ Time Frame: 24 months ]Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

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Ages Eligible for Study: | up to 1 Month (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- neonates with admission on neonatal intensive care unit with congenital heart disease.
Exclusion Criteria:
- No informed consent.

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
Contact: Liesbeth Thewissen, MD | +3216342569 | liesbeth.thewissen@uzleuven.be |
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 |
Principal Investigator: | Liesbeth Thewissen, MD | UZ Leuven |
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 |