Infant Nasal Nitric Oxide Levels in Congenital Heart Disease

NCT02551107 | Terminated

• 1 other identifier: 2015-LR-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• nasal NO level in parts per billion (ppb)

  1 minute

Study Arms (2)

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.

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.

Device: Measurement of nasal Nitric Oxide level

Interventions

Measurement of nasal Nitric Oxide level DEVICE

ECO MEDICS CLD 88 sp Nitric Oxide Analyzer

Congenital heart disease; Controls

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 16, 2015
• Study Start: December 1, 2015
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)