Maternal; Chorioamnionitis, Affecting FetusNCT04513691
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
An observational study of Maternal; Chorioamnionitis, Affecting Fetus and Early-Onset Sepses, Neonatal, run by Pediatrix at 1 site in United States.
Trial summary
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Maternal; Chorioamnionitis, Affecting Fetus, Early-Onset Sepses, Neonatal
- What is being tested?
- EOS Calculator
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 10 Aug 2022
- 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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix April 28, 2018 through April 28, 2020 whose mothers were determined or suspected to have CAM.
Who may be able to join
- Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.
Who cannot join
- Direct NICU Admissions
- Subjects may be excluded at Investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: A Retrospective Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Newborns enrolled will be at least 35 weeks gestational age (GA) and have a maternal diagnosis of at least suspected or confirmed CAM. The data will include those newborns whose assessment and treatment were not guided by the EOS calculator which was implemented on August 28, 2019 and those with which the EOS calculator was utilized. A secondary objective is to show the economic impact with utilization of the EOS calculator. Data collected will include full laboratory workups including complete blood counts (CBC), blood cultures, antibiotic usage, length of time in the newborn nursery and total length of stay.
- Being tested
- EOS Calculator
- Medical subject headings
- Chorioamnionitis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS CalculatorDiagnostic test
Neonatal Early-Onset Sepsis Risk Calculator which is a tool that determines the risk of EOS for a particular newborn by looking at maternal risk factors and the newborn's clinical picture as opposed to just laboratory tests alone
| Study group | Role | What they receive |
|---|---|---|
| Sample | Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM. Receives: Diagnostic Test: EOS Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the usage of Neonatal EOS Calculator decreased antibiotic usage in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
To determine the usage of EOS Calculator measuring decreased antibiotic usage.
Measured: August 28, 2018 through August 28, 2020
To determine whether the usage of Neonatal EOS Calculator measuring laboratory testing in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
To determine the usage of EOS Calculator measuring laboratory testing.
Measured: August 28, 2018 through August 28, 2020
To determine whether the usage of Neonatal EOS Calculator LOS in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns
Measured: August 28, 2018 through August 28, 2020
Secondary outcomes (3)
To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.
Evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage.
Measured: August 28, 2018 through August 28, 2020
To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.
Evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests.
Measured: August 28, 2018 through August 28, 2020
To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.
Evaluate the economic impact after the implementation of the EOS Calculator LOS in newborn nursery and total length of hospital stay.
Measured: August 28, 2018 through August 28, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start30 Sep 2020
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal; Chorioamnionitis, Affecting FetusStudies 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
- Cross-sectional
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513691
- Sponsor's protocol ID
- 641575377
- Status last verified
- Sep 2022
- First submitted
- 6 Aug 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
- ClinicalTrials.gov ID
- NCT04513691
- Acronym / sponsor ID
- 641575377
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 14 Aug 2020 (actual)
- 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.
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Newborns enrolled will be at least 35 weeks gestational age (GA) and have a maternal diagnosis of at least suspected or confirmed CAM. The data will include those newborns whose assessment and treatment were not guided by the EOS calculator which was implemented on August 28, 2019 and those with which the EOS calculator was utilized. A secondary objective is to show the economic impact with utilization of the EOS calculator. Data collected will include full laboratory workups including complete blood counts (CBC), blood cultures, antibiotic usage, length of time in the newborn nursery and total length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample | – | Diagnostic Test: EOS CalculatorAsymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix April 28, 2018 through April 28, 2020 whose mothers were determined or suspected to have CAM.
Key inclusion criteria (1 listed)
- Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.
Key exclusion criteria (2 listed)
- Direct NICU Admissions
- Subjects may be excluded at Investigator discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS CalculatorNeonatal Early-Onset Sepsis Risk Calculator which is a tool that determines the risk of EOS for a particular newborn by looking at maternal risk factors and the newborn's clinical picture as opposed to just laboratory tests alone | Diagnostic test | Sample |
Primary outcome
To determine whether the usage of Neonatal EOS Calculator decreased antibiotic usage in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
Time frame: August 28, 2018 through August 28, 2020
To determine the usage of EOS Calculator measuring decreased antibiotic usage.
To determine whether the usage of Neonatal EOS Calculator measuring laboratory testing in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
Time frame: August 28, 2018 through August 28, 2020
To determine the usage of EOS Calculator measuring laboratory testing.
To determine whether the usage of Neonatal EOS Calculator LOS in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.
Time frame: August 28, 2018 through August 28, 2020
To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns
3 secondary outcomes
To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.
Time frame: August 28, 2018 through August 28, 2020
To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.
Time frame: August 28, 2018 through August 28, 2020
To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.
Time frame: August 28, 2018 through August 28, 2020
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 22 Nov 2022.
- Individual participant dataSharing planned: No
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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 Maternal; Chorioamnionitis, Affecting Fetus and Early-Onset Sepses, Neonatal, 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 1 inclusion and 2 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 22 Nov 2022. 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 determine whether the usage of Neonatal EOS Calculator decreased antibiotic usage in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery. (time frame: August 28, 2018 through August 28, 2020). The study lists 3 primary outcomes in all. 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 22 Nov 2022.