Airway Inflammation in Congenital Diaphragmatic Hernia Patients

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Congenital Diaphragmatic Hernia
Interventions
DRUG

Hypersaline

Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls \<10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls \>10%, the previous step will be repeated.

DRUG

Bronchodilator Response

A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT02453750 - Airway Inflammation in Congenital Diaphragmatic Hernia Patients | Biotech Hunter | Biotech Hunter