Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

Heart Defects, Congenital Clinical Trial

— CHD-NIRS  

Official title:

Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679275
• Other study ID #: S54683
• Status: Completed
• Start date: October 2012
• Est. completion date: June 2018

Study information

• Verified date: May 2018
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent. (for the long term neurodevelopmental FU)

• no cerebral oxygen saturation in the first 3 day's of life

• gestational age < 37 weeks

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• measuring cerebral oxygenation

Locations

Country	Name	City	State
Belgium	Neonatal Intensive Care Unit UZLeuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental follow up at 24 months	Neurodevelopmental assessment at 24 months using Bayley scales of infant development II	24 months
Secondary	cerebrovascular changes in the transitional phase	Cerebral oxygen saturation and autoregulatory capacity	first 3 days of life
Secondary	Association of cerebrovascular changes with short term outcome	short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge	time frame of 1 admission