NCT01215461

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
645

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

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

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

October 5, 2010

Last Update Submit

May 13, 2013

Conditions

Neonatal Mortality

Keywords

Neonatal mortalityPreterm birthLow gestational ageVLBW

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age22 Weeks - 44 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates for whom healthcare was provided.

You may qualify if:

  • Neonates for whom healthcare was provided
  • Born alive
  • Neonate greater than or equal to 22 0/7 weeks estimated gestational age

You may not qualify if:

  • Stillborn
  • Fetal demise
  • Neonates less than or equal to 21 6/7 weeks estimated gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 6, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

US(1)