Factors Associated With Mortality in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01215461
First received: October 5, 2010
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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
Neonatal Mortality

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Factors Associated With Mortality in Neonates

Further study details as provided by Pediatrix Medical Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 645
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   22 Weeks to 44 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215461

Locations
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT01215461     History of Changes
Other Study ID Numbers: PDX-001-10
Study First Received: October 5, 2010
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Neonatal mortality
Preterm birth
Low gestational age
VLBW

ClinicalTrials.gov processed this record on October 23, 2014