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Infant Nasal Nitric Oxide Levels in Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT02551107
Recruitment Status : Terminated (Inadequate resources)
First Posted : September 16, 2015
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
Lindsay Ryerson, University of Alberta

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Device: Measurement of nasal Nitric Oxide level Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Nasal Nitric Oxide Levels in Infants With and Without Congenital Heart Disease
Study Start Date : December 2015
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Congenital heart disease

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.

Device: Measurement of nasal Nitric Oxide level
ECO MEDICS CLD 88 sp Nitric Oxide Analyzer

Active Comparator: Controls
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.
Device: Measurement of nasal Nitric Oxide level
ECO MEDICS CLD 88 sp Nitric Oxide Analyzer




Primary Outcome Measures :
  1. nasal NO level in parts per billion (ppb) [ Time Frame: 1 minute ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551107


Locations
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Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada

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Responsible Party: Lindsay Ryerson, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02551107     History of Changes
Other Study ID Numbers: 2015-LR-01
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents