Neonatal MortalityNCT01215461
Factors Associated With Mortality in Neonates
An observational study of Neonatal Mortality, run by Pediatrix at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 44 weeks
- Conditions the study is for
- Neonatal Mortality
- How many people
- 645 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates for whom healthcare was provided.
Who may be able to join
- Neonates for whom healthcare was provided
- Born alive
- Neonate greater than or equal to 22 0/7 weeks estimated gestational age
Who cannot join
- Stillborn
- Fetal demise
- Neonates less than or equal to 21 6/7 weeks estimated gestational age
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Alaska Medical Center
Anchorage, Alaska, 99508
About this study
Official title: 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.
- Conditions
- Neonatal Mortality
- Keywords
- Neonatal mortality, Preterm birth, Low gestational age, VLBW
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care.
Measured: neonatal outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215461
- Sponsor's protocol ID
- PDX-001-10
- Status last verified
- May 2013
- First submitted
- 5 Oct 2010
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Associated With Mortality in Neonates
- ClinicalTrials.gov ID
- NCT01215461
- Acronym / sponsor ID
- PDX-001-10
- Conditions
- Neonatal Mortality
- Keywords
- Neonatal mortality, Preterm birth, Low gestational age, VLBW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates for whom healthcare was provided.
Key inclusion criteria (3 listed)
- Neonates for whom healthcare was provided
- Born alive
- Neonate greater than or equal to 22 0/7 weeks estimated gestational age
Key exclusion criteria (3 listed)
- Stillborn
- Fetal demise
- Neonates less than or equal to 21 6/7 weeks estimated gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Mortality, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.