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
Protocol serial number	WHO/CAH ID 99025
Sponsor	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Funder	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

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

World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Email	qazis@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/04/2002

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	59 Months
Sex	All
Target sample size at registration	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

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?
Results article	Results	01/11/2004		Yes	No