Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Other: measuring cerebral oxygenation

• Registration Number: NCT01679275
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Study Start: 2012-10
• Status Verified: 2018-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
measuring cerebral oxygenation	measuring cerebral oxygenation	NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease.

Primary Outcome Measures

Name	Time	Method
Neurodevelopmental follow up at 24 months	24 months	Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

Secondary Outcome Measures

Name	Time	Method
Association of cerebrovascular changes with short term outcome	time frame of 1 admission	short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge
cerebrovascular changes in the transitional phase	first 3 days of life	Cerebral oxygen saturation and autoregulatory capacity

Trial Locations

Locations (1)

Neonatal Intensive Care Unit UZLeuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium