Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis (Chorio)

May 28, 2025 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

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27408-7079
        • Women's Hospital of Greensboro

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

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

Pediatrix

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 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

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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