Airway Inflammation in Congenital Diaphragmatic Hernia Patients

The Hospital for Sick Children

Status: Completed

Conditions: Congenital Diaphragmatic Hernia

Treatments: Drug: Bronchodilator Response; Drug: Hypersaline

Study type: Interventional

Funder types: Other

Identifiers

NCT02453750

1000028032

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Hypersaline and Bronchodilator Response

Experimental group

Description:

After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.

Treatment:

Drug: Hypersaline

Drug: Bronchodilator Response