NCT00198887

Brief Summary

This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59,651

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2003

Completed
2.7 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 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

September 12, 2005

Last Update Submit

July 3, 2007

Conditions

Pregnancy Complications

Keywords

newbornoperations researchnewborn survivalNeonatal illness/mortalityDelivery complications

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality rate

Secondary Outcomes (3)

  • Cost of delivering the intervention, per newborn

  • Changes in behavioral indicators

  • Change in program coverage

Interventions

Operations researchPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Newborn

You may not qualify if:

  • Infant/child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King George's Medical College

Lucknow, Uttar Pradesh, India

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mathuram Santosham, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Study Completion

October 1, 2006

Last Updated

July 6, 2007

Record last verified: 2007-07

Locations

IN(1)