NCT00198705

Brief Summary

This project delivers, promotes and facilitates services related to pregnancy, delivery and newborn care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,670

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Last Update Submit

September 12, 2014

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality rate

Secondary Outcomes (2)

  • Neonatal colonization with antibiotic-resistant bacteria

  • Cost of providing the intervention services per neonate

Interventions

Improved management of severe neonatal infectionsBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • participants consenting for the home-based care model area
  • participants who consent for household adequacy survey
  • participants who consent from clinic care model area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Dhaka, Bangladesh

Location

Related Publications (2)

  • Baqui AH, Ahmed S, El Arifeen S, Darmstadt GL, Rosecrans AM, Mannan I, Rahman SM, Begum N, Mahmud AB, Seraji HR, Williams EK, Winch PJ, Santosham M, Black RE; Projahnmo 1 Study Group. Effect of timing of first postnatal care home visit on neonatal mortality in Bangladesh: a observational cohort study. BMJ. 2009 Aug 14;339:b2826. doi: 10.1136/bmj.b2826.

    PMID: 19684100DERIVED

  • Baqui AH, El-Arifeen S, Darmstadt GL, Ahmed S, Williams EK, Seraji HR, Mannan I, Rahman SM, Shah R, Saha SK, Syed U, Winch PJ, Lefevre A, Santosham M, Black RE; Projahnmo Study Group. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet. 2008 Jun 7;371(9628):1936-44. doi: 10.1016/S0140-6736(08)60835-1.

    PMID: 18539225DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdullah Baqui

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, International Health and Director, International Center for Maternal and Newborn Health

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2003

Primary Completion

July 1, 2007

Study Completion

August 1, 2012

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

BA(1)