Condition category
Neonatal Diseases
Date applied
09/09/2005
Date assigned
01/02/2006
Last edited
02/03/2011
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 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 measures

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

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

http://www.who.int

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21239052

Publication citations

  1. 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.

Additional files

Editorial Notes