Contact information
Type
Scientific
Primary contact
Dr Shamim Ahmad Qazi
ORCID ID
Contact details
Department of Child and Adolescent Health and Development
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 22 791 2547
qazis@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCH06001
Study information
Scientific title
Acronym
Study hypothesis
Promotion of care-seeking for ARI Needing Assessment (ANA) in children zero to 59 months of age, leads mothers to increasingly seek care from Lady Health Workers (LHW) or other appropriate providers with in 24 hours of recognising ANA in their children.
Ethics approval
Institutional Review Board of Save the Children, Pakistan and Ethical Review Committee of the World Health Organization (WHO), Geneva, approval gained on the 18/07/2006.
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pneumonia and severe pneumonia in children zero to 59 months old.
Intervention
1. Sensitisation workshop/seminar at district level of district officials and elected representatives on ARI - once at the start of the trial
2. Sensitisation workshop/seminar on ARI at community level at Rural Health Center level - two in a year
3. Training of Lady Health Workers (LHW) on ARI counselling skills and ARI case management - once at the start of the trial
4. Orientation of male activists in communications skills and use of Information Education and Communication (IEC) material - once at the start of the trial
5. Community Awareness Sessions (CAS) at mohalla level for males and females once every month and household visits (five to seven houses) by LHW daily
Of 28 clusters, LHWs in 14 clusters will be randomised to enhanced ARI case management training, which will include management of non-severe and severe pneumonia under supervision and LHWs in the other 14 clusters will be randomised to the standard ARI case management, which will only include management of non-severe pneumonia working in those clusters - once at the start of the trial. One Union council in the district is one cluster.
The Principal Investigator for this trial is:
Dr Abdul Bari
Save the Children US
House No. 5, Street No. 29
Sector F-7/1, Islamabad
Pakistan
Telephone: +92 51 111 107 108/ext. 106
Email: drabdulbari99@yahoo.com
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To see the proportionate change in care-seeking by mothers and care-takers for ANA among children zero to 59 months old. This change in care-seeking will be assessed for both from LHW and other appropriate health care providers.
Secondary outcome measures
1. To compare the enhanced ARI case management with standard ARI case management for the clinical outcome (cure or failure) for the management of pneumonia at the community level in children up to 59 months old
2. The signs and symptoms used by LHW to classify the ARI in children
3. Compliance by the mother to LHW referral to nearest public health facility
4. Outcome of the referral
Overall trial start date
01/10/2006
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For improving careseeking practices component, mothers of all zero to 59 months old children in the 28 union councils of District Haripur. For the ARI standard case management component, children up to 59 months of age.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
85481
Participant exclusion criteria
1. Mothers who refuse to take part in the careseeking components
2. Children with pneumonia, whose mother/parents refuse to accept ARI case management by the LHW and those who have danger signs like:
2.1. Inability to drink
2.2. Difficult to awake/drowsy/unconscious
2.3. Grunting
2.4. Cyanosis
2.5. Convulsions
2.6. Severe respiratory distress
Recruitment start date
01/10/2006
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Pakistan
Trial participating centre
Department of Child and Adolescent Health and Development
Geneva-27
CH 1211
Switzerland
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organisation (WHO) (Switzerland) (ref: NCH06001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22078721
Publication citations
-
Results
Bari A, Sadruddin S, Khan A, Khan Iu, Khan A, Lehri IA, Macleod WB, Fox MP, Thea DM, Qazi SA, Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial., Lancet, 2011, 378, 9805, 1796-1803, doi: 10.1016/S0140-6736(11)61140-9.