Condition category
Infections and Infestations
Date applied
04/10/2006
Date assigned
09/10/2006
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

Department of Child and Adolescent Health and Development
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22078721

Publication citations

  1. 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.

Additional files

Editorial Notes