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N/A Completed N=21 Diagnostic

Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Congenital Diaphragmatic Hernia
Source: ClinicalTrials.gov NCT02453750 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Elevated Sputum Eosinophils — 0 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Elevated Sputum Eosinophils
SECONDARY
Number of Participant With Elevated Sputum Neutrophils
SECONDARY
Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level
2
SECONDARY
Number of Participant With Bronchodilator Response
15

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02453750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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