Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

NCT01679275 | Completed

• 1 other identifier: S54683
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental follow up at 24 months

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

  24 months

Secondary Outcomes (2)

• cerebrovascular changes in the transitional phase

  first 3 days of life

• Association of cerebrovascular changes with short term outcome

  time frame of 1 admission

Study Arms (1)

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

Interventions

measuring cerebral oxygenation OTHER

measuring cerebral oxygenation

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

infants with congenital heart defect

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Neonatal Intensive Care Unit UZLeuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Liesbeth Thewissen, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 30, 2023

Record last verified: 2018-05

Locations

BE (1)