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Factors Associated With Mortality in Neonates

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ClinicalTrials.gov Identifier: NCT01215461
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief 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.

Condition or disease
Neonatal Mortality

Study Type : Observational
Actual Enrollment : 645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Factors Associated With Mortality in Neonates
Study Start Date : September 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   22 Weeks to 44 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates for whom healthcare was provided.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215461


Locations
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety

Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT01215461     History of Changes
Other Study ID Numbers: PDX-001-10
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Neonatal mortality
Preterm birth
Low gestational age
VLBW