Heart Defects, CongenitalCHD-NIRSNCT01679275
Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
An observational study of Heart Defects, Congenital, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- measuring cerebral oxygenation
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: infants with congenital heart defect
Who may be able to join
- neonates with admission on neonatal intensive care unit with congenital heart disease.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Neonatal Intensive Care Unit UZLeuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy 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.
- Conditions
- Heart Defects, Congenital
- Being tested
- measuring cerebral oxygenation
- Keywords
- Heart Defects, congenital, Patient Monitoring, Infant, Newborn, Physiology
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring cerebral oxygenationOther
| Study group | Role | What they receive |
|---|---|---|
| measuring cerebral oxygenation | NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease. Receives: Other: measuring cerebral oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental follow up at 24 months
Neurodevelopmental assessment at 24 months using Bayley scales of infant development II
Measured: 24 months
Secondary outcomes (2)
cerebrovascular changes in the transitional phase
Cerebral oxygen saturation and autoregulatory capacity
Measured: first 3 days of life
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
Measured: time frame of 1 admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth Thewissen, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679275
- Sponsor's protocol ID
- S54683
- Acronym
- CHD-NIRS
- Status last verified
- May 2018
- First submitted
- 31 Aug 2012
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.
- ClinicalTrials.gov ID
- NCT01679275
- Acronym / sponsor ID
- CHD-NIRS / S54683
- Conditions
- Heart Defects, Congenital
- Keywords
- Heart Defects, congenital, Patient Monitoring, Infant, Newborn, Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measuring cerebral oxygenation | – | Other: measuring cerebral oxygenationNIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants with congenital heart defect
Key inclusion criteria (1 listed)
- neonates with admission on neonatal intensive care unit with congenital heart disease.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring cerebral oxygenation | Other | measuring cerebral oxygenation |
Primary outcome
Neurodevelopmental follow up at 24 months
Time frame: 24 months
Neurodevelopmental assessment at 24 months using Bayley scales of infant development II
2 secondary outcomes
cerebrovascular changes in the transitional phase
Time frame: first 3 days of life
Association of cerebrovascular changes with short term outcome
Time frame: time frame of 1 admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liesbeth Thewissen, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental follow up at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.