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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55153521
Enrollment
82
Registered
2005-03-22
Start date
2005-01-01
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lung disease of infancy or bronchopulmonary dysplasia Respiratory Chronic lung disease

Interventions

Children will receive inhaled corticosteroids or placebo for 6 weeks, pulmonary function either forced expiratory volume in 1 second (FEV1) or impulse oscillometry and quality of life will be assessed

Sponsors

University of Calgary (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026