Ceftriaxone and Jaundice in Neonates

NCT ID: NCT03133637

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-08-31

Brief Summary

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Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for sepsis and investigators will observe the effect on jaundice.

Detailed Description

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Conditions

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Jaundice and Sepsis in Neonates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ceftriaxone Arm

ceftriaxone

Intervention Type DRUG

Eligible infants will receive ceftriaxone as standard of care for sepsis

Interventions

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ceftriaxone

Eligible infants will receive ceftriaxone as standard of care for sepsis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life.

Exclusion Criteria

* Infants with asphyxia (Apgar score \<3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home.
Minimum Eligible Age

3 Days

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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29287

Identifier Type: -

Identifier Source: org_study_id

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