Ceftriaxone and Jaundice in Neonates

Effect of Ceftriaxone on Neonatal Jaundice

Sponsors

Lead Sponsor: Sanjiv Amin

Source 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. The effect of ceftriaxone on jaundice has not been investigated in well designed studies

Detailed Description

The ceftriaxone may affect jaundice concentration specifically binding of bilirubin to albumin. The study will evaluate the effect of ceftriaxone on bilirubin binding in neonates with a diagnosis of sepsis.

Overall Status Completed
Start Date March 2016
Completion Date August 31, 2019
Primary Completion Date August 31, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
change in bilirubin binding assays baseline and through study completion, an average of 1 hour
Secondary Outcome
Measure Time Frame
Automated brain stem evoke response test through study completion, an average of 1 hour
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: ceftriaxone

Description: Eligible infants will receive ceftriaxone

Arm Group Label: Ceftriaxone Arm

Eligibility

Criteria:

Inclusion Criteria:

- infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin < 12 mg/dL but otherwise stable and healthy to be discharged home

Exclusion Criteria:

- Infants with asphyxia, chromosomal disorder, hearing loss, moderate to severe jaundice, unstable clinical conditions, respiratory distress, cardiac disorders, and any clinical conditions which will preclude discharge to home.

Gender: All

Minimum Age: N/A

Maximum Age: 7 Days

Healthy Volunteers: No

Location
Facility: University of Rochester Medical Center
Location Countries

United States

Verification Date

September 2019

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Rochester

Investigator Full Name: Sanjiv Amin

Investigator Title: Professor of Pediatrics

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ceftriaxone Arm

Type: Experimental

Acronym CEFT
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov