The role of inhaled corticosteroids in children with chronic lung disease of Infancy

Not Applicable

Completed

• Conditions: Chronic lung disease of infancy or bronchopulmonary dysplasia; Respiratory; Chronic lung disease

• Registration Number: ISRCTN55153521
• Lead Sponsor: niversity of Calgary (Canada)

Brief Summary

Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/15826314

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-22
• Study Completion: 2005-12-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. 3 - 7 year old children with history of chronic lung disease of infancy
2. Premature birth at 36 weeks gestation or less
3. Clinical and radiological diagnosis of CLD. Patient charts will be reviewed and the x-rays will be reviewed, even if there is no x-ray findings patients will be included if they fulfil the other criteria.
4. Requirement of supplemental oxygen to maintain saturation of 90%, for at least 36 weeks corrected gestation

Exclusion Criteria

1. Cardiovascular disease other than patent ductus arteriosus (PDA)
2. Those with severe neurological disease or developmental delay
3. Oxygen requirement for respiratory diagnosis other than CLD, e.g., congenital diaphragmatic hernia and aspiration
4. An inability to perform spirometry or impulse oscillometry (IOS)
5. Noncompliance with therapy
6. Pneumonia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in respiratory system resistance at 5 Hz frequency using impulse oscillometry after 6 weeks of inhaled corticosteroids in CLD.

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life system score using Child Health Questionnaire (CHQ) and FEV1 response to bronchodilators (Salbutamol) after inhaled corticosteroids treatment for 6 weeks in CLD.