Contact information
Type
Scientific
Primary contact
Dr Jose Martines
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
martinesj@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01006HNI
Study information
Scientific title
Acronym
Study hypothesis
The promotion of improved newborn care by first level health workers (traditional birth attendants, lady health workers and midwives) together with increased community participation in newborn care will lead to a substantial reduction in neonatal and perinatal mortality.
Ethics approval
Ethics approval received on the 21st June 2005.
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Newborn sepsis, birth asphyxia, pneumonia
Intervention
1. Improved newborn care by first level health workers (traditional birth attendants, lady health workers and midwives)
2. Increased community participation in newborn care
For further information please contact Dr Martines at the address listed below or the principal investigator:
Dr Zulfiqar Bhutta
Department of Paediatric and Child Health
Aga Khan University
Stadium Road
Karachi
P.O. Box 3500
Pakistan
Email: zulfiqar.bhutta@aku.edu
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Newborn mortality
2. Perinatal mortality
Secondary outcome measures
1. Early initiation of breastfeeding
2. Exclusive breastfeeding
Overall trial start date
01/08/2002
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All newborns in the study community are eligible for inclusion.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
36,000
Participant exclusion criteria
Refusal to participate.
Recruitment start date
01/08/2002
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Pakistan
Trial participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
martinesj@who.int
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Saving Newborn Lives (SNL) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
United Nations Children's Fund (UNICEF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Government of Pakistan (Pakistan)
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/21239052
Publication citations
-
Results
Bhutta ZA, Soofi S, Cousens S, Mohammad S, Memon ZA, Ali I, Feroze A, Raza F, Khan A, Wall S, Martines J, Improvement of perinatal and newborn care in rural Pakistan through community-based strategies: a cluster-randomised effectiveness trial., Lancet, 2011, 377, 9763, 403-412, doi: 10.1016/S0140-6736(10)62274-X.