Congenital Heart DiseaseNCT02551107
Infant Nasal Nitric Oxide Levels in Congenital Heart Disease
A study testing Measurement of nasal Nitric Oxide level in people with Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
Trial summary
This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched controls without CHD. Read more about this study
- Who is it for?
- Ages 1 day to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Measurement of nasal Nitric Oxide level
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to 12 Jan 2018
- Phase
- Interventional
- 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 1 day to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography.
Who cannot join
- All patients, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography.
- Control group:
- The control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. They will also require written informed consent and will have to be breathing room air at the time of the nNO test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Nitric Oxide Levels in Infants With and Without Congenital Heart Disease
This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched controls without CHD. CHD patients will be divided into subgroups, based on their cardiac anatomy, to try and identify a level of risk of ciliary dyskinesia within the subgroup of CHD. Each of these sub groups' nNO levels will be compared between groups and against age matched control infants without CHD.
Read the detailed description
Methods: Parents or legal guardians will be approached to provide written, informed consent. To allow for at least three sub groups of cardiac anomalies (with 20 patients per group), 60 children, less than one year of age, with CHD will be recruited from the Pediatric Cardiology inpatient ward at Stollery Children's Hospital. Sixty age matched controls, without acute respiratory illness, will be recruited from the General Pediatric inpatient ward. All subjects will be breathing room air at the time of nNO measurement.
Subjects: This is a pilot study to gather data to power future studies. The investigators aim to recruit 60 subjects with CHD and 60 normal controls without CHD. 60 subjects will allow for at least three sub groups of cardiac anomalies with 20 subjects per group.
Control group: The control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. They will also require written informed consent and will have to be breathing room air at the time of the nNO test.
Investigational device: For nNO assessment, an inert nitric oxide (NO) sampling line with a disposable foam olive (DirectMed Inc., Glen Cove, NY) will be placed into one of the subject's nostrils while the contralateral nostril is left open. Air will be then sampled at a constant rate of 0.3 Liters/min from the nose by a chemiluminescent analyzer which provides measurement of the nNO level in parts per billion (ppb). All nNO measurements will be performed with the subjects supine. Measurements will be obtained using a NO analyzer (CLD 88 SP, ECO PHYSICS AG, Duerten, Switzerland) available at Stollery Children's Hospital. The analyzer will be calibrated according to the manufacturer's specifications. Two samples will be taken five minutes apart, to assess for test-retest reproducibility, with results for each patient being averaged over the two samples. The test is not painful and each sample takes less than a minute.
- Conditions
- Congenital Heart Disease
- Being tested
- Measurement of nasal Nitric Oxide level
- 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.
Measurement of nasal Nitric Oxide levelDevice
ECO MEDICS CLD 88 sp Nitric Oxide Analyzer
| Study group | Role | What they receive |
|---|---|---|
| Congenital heart disease | Experimental | Inclusion criteria: All participants, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography.
Exclusion criteria: Participants with only PDA or PFO, without written informed consent, patients older than one year of age or any subject on oxygen at the time of nNO assessment. Receives: Device: Measurement of nasal Nitric Oxide level |
| Controls | Active comparator | The control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. The participants will also require written informed consent and will have to be breathing room air at the time of the nNO test. Receives: Device: Measurement of nasal Nitric Oxide level |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal NO level in parts per billion (ppb)
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startDec 2015
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Why it stopped: Inadequate resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Principal investigator, Lindsay Ryerson, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551107
- Sponsor's protocol ID
- 2015-LR-01
- Status last verified
- Jan 2018
- First submitted
- 14 Sep 2015
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Nitric Oxide Levels in Infants With and Without Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02551107
- Acronym / sponsor ID
- 2015-LR-01
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate resources
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Study start
- Dec 2015
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 16 Sep 2015 (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.
This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched controls without CHD. CHD patients will be divided into subgroups, based on their cardiac anatomy, to try and identify a level of risk of ciliary dyskinesia within the subgroup of CHD. Each of these sub groups' nNO levels will be compared between groups and against age matched control infants without CHD.
Detailed description
Methods: Parents or legal guardians will be approached to provide written, informed consent. To allow for at least three sub groups of cardiac anomalies (with 20 patients per group), 60 children, less than one year of age, with CHD will be recruited from the Pediatric Cardiology inpatient ward at Stollery Children's Hospital. Sixty age matched controls, without acute respiratory illness, will be recruited from the General Pediatric inpatient ward. All subjects will be breathing room air at the time of nNO measurement.
Subjects: This is a pilot study to gather data to power future studies. The investigators aim to recruit 60 subjects with CHD and 60 normal controls without CHD. 60 subjects will allow for at least three sub groups of cardiac anomalies with 20 subjects per group.
Control group: The control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. They will also require written informed consent and will have to be breathing room air at the time of the nNO test.
Investigational device: For nNO assessment, an inert nitric oxide (NO) sampling line with a disposable foam olive (DirectMed Inc., Glen Cove, NY) will be placed into one of the subject's nostrils while the contralateral nostril is left open. Air will be then sampled at a constant rate of 0.3 Liters/min from the nose by a chemiluminescent analyzer which provides measurement of the nNO level in parts per billion (ppb). All nNO measurements will be performed with the subjects supine. Measurements will be obtained using a NO analyzer (CLD 88 SP, ECO PHYSICS AG, Duerten, Switzerland) available at Stollery Children's Hospital. The analyzer will be calibrated according to the manufacturer's specifications. Two samples will be taken five minutes apart, to assess for test-retest reproducibility, with results for each patient being averaged over the two samples. The test is not painful and each sample takes less than a minute.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital heart disease | Experimental | Device: Measurement of nasal Nitric Oxide levelInclusion criteria: All participants, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography. Exclusion criteria: Participants with only PDA or PFO, without written informed consent, patients older than one year of age or any subject on oxygen at the time of nNO assessment. |
| Controls | Active comparator | Device: Measurement of nasal Nitric Oxide levelThe control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. The participants will also require written informed consent and will have to be breathing room air at the time of the nNO test. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography.
Key exclusion criteria (3 listed)
- All patients, less than one year of age, with CHD will be eligible for this study with the exception of those patients with only patent foramen ovale (PFO) and patent ductus arteriosus (PDA). The diagnosis of CHD will be confirmed by echocardiography.
- The control group will consist of age matched infants, less than one year of age, without CHD or acute respiratory illness. They will also require written informed consent and will have to be breathing room air at the time of the nNO test.
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 |
|---|---|---|
| Measurement of nasal Nitric Oxide levelECO MEDICS CLD 88 sp Nitric Oxide Analyzer | Device | Congenital heart disease, Controls |
Primary outcome
nasal NO level in parts per billion (ppb)
Time frame: 1 minute
Results and safety
The study was stopped early (reason given: Inadequate resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of nasal Nitric Oxide level in people with Congenital Heart Disease, run by University of Alberta at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 24 Jan 2018. 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 Canada. 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 was stopped early (reason given: Inadequate resources). Results are not available in the source record.
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?
nasal NO level in parts per billion (ppb) (time frame: 1 minute). 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 24 Jan 2018.