Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01679275

Acronym

CHD-NIRS

Enrollment

Registered

2012-09-05

Start date

2012-10-31

Completion date

2018-06-30

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects, Congenital

Keywords

Heart Defects, congenital, Patient Monitoring, Infant, Newborn, Physiology

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.

Interventions

OTHERmeasuring cerebral oxygenation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Neurodevelopmental follow up at 24 months	24 months	Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

Secondary

Measure	Time frame	Description
cerebrovascular changes in the transitional phase	first 3 days of life	Cerebral oxygen saturation and autoregulatory capacity
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026