Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Not Applicable

Completed

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Drug: Hypersaline; Drug: Bronchodilator Response

• Registration Number: NCT02453750
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-25
• Results First Submitted: 2017-10-06
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 6 - 18 years of age at enrolment
• Clinically stable at enrolment
• Attending follow-up in the CDH Clinic at SickKids

Exclusion Criteria

• Unable to perform pulmonary function testing
• Clinically unstable at enrolment
• Known hypersensitivity to salbutamol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypersaline and Bronchodilator Response	Bronchodilator Response	After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
Hypersaline and Bronchodilator Response	Hypersaline	After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Elevated Sputum Eosinophils	post sputum induction	Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum

Secondary Outcome Measures

Name	Time	Method
Number of Participant With Bronchodilator Response	life time of child (age 6 to present age)	defined as a = or \> 12% change in FEV1 post bronchodilator
Number of Participant With Elevated Sputum Neutrophils	Baseline, +30 minutes	Elevation is defined as sputum neutrophils \> or = 61% neutrophils = neutrophilic inflammation
Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level	30 min	exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.; greater than 20 ppb was considered elevated

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada