Selective Use of Antibiotics in Neonates Born to Mothers... | NCT03576560

Studies
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis

NCT03576560

Sponsor

Pediatrix

Status

Completed

Last Update Posted

Jun 3, 2025Actual

Enrollment

768Actual

Phase

Not provided

Conditions

Chorioamnionitis

Interventions

Retrospective Chart Review

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2017Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2025

Last Update Posted Date

Jun 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

768Actual

Name	Type	Description	Arm Group Labels	Other Names
Retrospective Chart Review	Other	Retrospective Chart Review

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review.	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Mother/baby in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever

Minimum Age

35 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Wimmer, MD	MEDNAX Employee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Hospital of Greensboro		Greensboro	North Carolina	27408-7079	United States

Condition Browse Module

MeSH Terms

ID	Term
D002821	Chorioamnionitis

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided