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
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01679275
First received: August 31, 2012
Last updated: December 7, 2015
Last verified: December 2015
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Purpose
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 |
Eligibility| Ages Eligible for Study: | up to 1 Month (Child) |
| Genders Eligible for Study: | Both |
| 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
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 ClinicalTrials.gov identifier: NCT01679275
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov 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 Physiology |
Additional relevant MeSH terms:
|
Heart Diseases Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Cardiovascular Abnormalities |
ClinicalTrials.gov processed this record on September 30, 2016