Factors Associated With Mortality in Neonates

May 13, 2013 updated by: Pediatrix

Evaluation of Factors Associated With Mortality in Neonates

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

645

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates for whom healthcare was provided.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care.
Time Frame: neonatal outcomes
neonatal outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PDX-001-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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