Assessment and management of children aged 1 - 59 months presenting with wheeze and fast breathing: multicenter study in Pakistan and Thailand
| ISRCTN | ISRCTN32365107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32365107 |
| Secondary identifying numbers | WHO/CAH ID 99025 |
- Submission date
- 27/07/2004
- Registration date
- 28/07/2004
- Last edited
- 11/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shamim Qazi
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
| qazis@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Using current World Health Organization (WHO) guidelines, children with wheezing are being over-prescribed antibiotics and bronchodilators are under utilised. To improve the WHO case management guidelines, more data is needed about the clinical outcome in children with wheezing/pneumonia overlap. |
| Ethics approval(s) | Ethics approval received fron: 1. Institutional Review Board (IRB) of Pakistan Institute of Medical Sciences, Islamabad, Pakistan 2. IRB of Queen Sirikit National Institute of Child Health, Bangkok, Thailand 3. World Health Organization (WHO) Ethical Review Committee |
| Health condition(s) or problem(s) studied | Wheeze and fast breathing |
| Intervention | 1. Inhaled Salbutamol and reassessment after up to three cycles of bronchodilator therapy repeated at 15 minute interval if necessary 2. Metered Dose Inhaler (MDI) with spacer device |
| Intervention type | Other |
| Primary outcome measure | Proportions of children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing: 1. Respond to up to three cycles of inhaled salbutamol: response defined as no fast breathing or lower chest indrawing present 2. Fail therapy at day 3 or days 5 - 7 of the initial successful bronchodilator therapy with inhaled salbutamol? Therapy failure defined as: 2.1. Relapse: develop fast breathing or chest indrawing afresh, that does not respond to three cycles of inhaled salbutamol 2.2. Development of any danger sign (except wheezing and fever in young infant) 2.3. Death 2.4. Severe adverse reaction to salbutamol |
| Secondary outcome measures | In children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing: 1. Proportion with audible wheeze at initial assessment 2. Proportion of responders to up to three cycles of inhaled salbutamol associated with: 2.1. Age 2.2. Respiratory Syncytial Virus (RSV) isolation 2.3. Season 2.4. Number of previous wheezing episodes 2.5. Audible versus auscultatory wheeze 2.6. Family history of asthma 3. Proportion of relapses in children who showed initial improvement associated with: 3.1. Age 3.2. RSV isolation 3.3. Season 3.4. Number of previous wheezing episodes 3.5. Audible versus auscultatory wheeze 3.6. Family history of asthma 4. Received any antibiotic for this or any concurrent illness before follow-up 5. Loss to follow-up 6. Withdrawal of consent |
| Overall study start date | 01/05/2001 |
| Completion date | 01/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1622 |
| Key inclusion criteria | 1. Age 1 to 59 months 2. Audible/auscultatory wheeze 3. Respiratory rate above age specific cut off point or lower chest indrawing 4. Classified as no pneumonia with wheeze |
| Key exclusion criteria | 1. Presence of danger sign: 1.1. Up to two months: stopped feeding well, drowsy, convulsions, stridor in a calm child, fever 1.2. 2 - 59 months: convulsions, clinically severe malnutrition, unable to drink 2. Antibiotics during last 48 hours |
| Date of first enrolment | 01/05/2001 |
| Date of final enrolment | 01/04/2002 |
Locations
Countries of recruitment
- Pakistan
- Switzerland
- Thailand
Study participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| Website | http://www.who.int/child-adolescent-health/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2004 | Yes | No |
