Skip to main content
OpenTrials
Completed

NCT Number: NCT01679275

Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Intensive Care Unit UZLeuven

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measuring cerebral oxygenation

Other

Primary outcomes

  1. Neurodevelopmental follow up at 24 months

    Time frame: 24 months

    Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

Secondary outcomes

  1. cerebrovascular changes in the transitional phase

    Time frame: first 3 days of life

    Cerebral oxygen saturation and autoregulatory capacity

  2. Association of cerebrovascular changes with short term outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: CHD-NIRS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2012
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.