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NCT01215461 Clinical Trial

Factors Associated With Mortality in Neonates

Neonatal Mortality Clinical Trial

Official title:
Evaluation of Factors Associated With Mortality in Neonates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01215461
Other study ID # PDX-001-10
Secondary ID
Status Completed
Phase N/A
First received October 5, 2010
Last updated May 13, 2013
Start date September 2010
Est. completion date October 2012

Study information
Verified date May 2013
Source Mednax Center for Research, Education and Quality
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.

Recruitment information / eligibility
Status Completed
Enrollment 645
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 22 Weeks to 44 Weeks
Eligibility Inclusion Criteria:

- Neonates for whom healthcare was provided

- Born alive

- Neonate greater than or equal to 22 0/7 weeks estimated gestational age

Exclusion Criteria:

- Stillborn

- Fetal demise

- Neonates less than or equal to 21 6/7 weeks estimated gestational age

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Providence Alaska Medical Center Anchorage Alaska

Sponsors (1)
Lead Sponsor Collaborator
Mednax Center for Research, Education and Quality

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. neonatal outcomes No
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