- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03576560
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis (Chorio)
June 20, 2019 updated by: Pediatrix
Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.
Study Type
Observational
Enrollment (Actual)
768
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Greensboro, North Carolina, United States, 27408-7079
- Women's Hospital of Greensboro
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months to 9 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.
Description
Inclusion Criteria:
• Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)
Exclusion Criteria: None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review.
Time Frame: Infants born from July, 2012 to December 31, 2018.
|
The retrospective chart review would analyze the total number of infants born to mothers with chorioamnionitis/intrapartum fever.
|
Infants born from July, 2012 to December 31, 2018.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Wimmer, MD, MEDNAX Employee
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2017
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
June 26, 2018
First Submitted That Met QC Criteria
June 26, 2018
First Posted (Actual)
July 3, 2018
Study Record Updates
Last Update Posted (Actual)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16NE-Z035-6145
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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