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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN10618300
Date of registration: 09/10/2006
Prospective Registration: No
Primary sponsor: World Health Organization (WHO) (Switzerland)
Public title: Effect of promotion of care-seeking for Acute Respiratory Infections (ARI) Needing Assessment (ANA) on the utilisation of lady health workers services for the management of acute respiratory infections among children aged zero to 59 months in district Haripur, Pakistan
Scientific title:
Date of first enrolment: 01/10/2006
Target sample size: 85481
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN10618300
Study type:  Interventional
Study design:  Randomised trial (Treatment)  
Phase: 
Countries of recruitment
Pakistan
Contacts
Name: Shamim Ahmad    Qazi
Address:  Department of Child and Adolescent Health and Development World Health Organization 20 Avenue Appia CH 1211 Geneva-27 Switzerland
Telephone: +41 22 791 2547
Email: qazis@who.int
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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.
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


Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Pneumonia and severe pneumonia in children zero to 59 months old.
Infections and Infestations
Pneumonia
Intervention(s)
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
Primary Outcome(s)
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(s)
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
Secondary ID(s)
NCH06001
Source(s) of Monetary Support
The Department of Child and Adolescent Health (CAH)/World Health Organisation (WHO) (Switzerland) (ref: NCH06001)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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