Ceftriaxone and Jaundice in Neonates

Completed

• Conditions: Jaundice and Sepsis in Neonates
• Interventions: Drug: ceftriaxone

• Registration Number: NCT03133637
• Lead Sponsor: University of Rochester

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ceftriaxone Arm	ceftriaxone	-

Primary Outcome Measures

Name	Time	Method
change in bilirubin binding assays	baseline and through study completion, an average of 1 hour

Secondary Outcome Measures

Name	Time	Method
Automated brain stem evoke response test	through study completion, an average of 1 hour

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States