The role of inhaled corticosteroids in children with chronic lung disease of Infancy
| ISRCTN | ISRCTN55153521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55153521 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 16027 |
| Sponsor | University of Calgary (Canada) |
| Funder | m Pharmaceuticals (Canada) - The pharmaceutical company is providing some funding (in the shape of free drug & placebo and spacers for the inhalers) |
- Submission date
- 11/03/2005
- Registration date
- 22/03/2005
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Saad Alotaibi
Scientific
Scientific
P.O. Box 951
Ardeyah City
92400
Kuwait
| saalotai@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The role of inhaled corticosteroids in children with chronic lung disease of Infancy |
| Study objectives | The aim of the study is to study the effect of inhaled steroids on school-aged children with chronic lung disease (CLD). The study hypothesis is that inhaled corticosteroids, Beclomethasone Dipropionate will improve respiratory system resistance after 6 weeks of treatment. |
| Ethics approval(s) | This study was approved by the conjoint Health Research Ethics Board and Child Health Research Committee at the University of Calgary, Alberta (Canada). |
| Health condition(s) or problem(s) studied | Chronic lung disease of infancy or bronchopulmonary dysplasia |
| Intervention | 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 before and after the intervention. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Beclomethasone Dipropionate |
| Primary outcome measure(s) |
Improvement in respiratory system resistance at 5 Hz frequency using impulse oscillometry after 6 weeks of inhaled corticosteroids in CLD. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 7 Years |
| Sex | All |
| Target sample size at registration | 82 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Canada
- Kuwait
Study participating centre
P.O. Box 951
Ardeyah City
92400
Kuwait
92400
Kuwait
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Study protocol | 12/04/2005 | Yes | No |
Editorial Notes
06/11/2019: Internal review.
