Ceftriaxone and Jaundice in Neonates

Jaundice and Sepsis in Neonates Clinical Trial

— CEFT  

Official title:

Effect of Ceftriaxone on Neonatal Jaundice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133637
• Other study ID #: 29287
• Status: Completed
• Start date: March 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice and Sepsis in Neonates

Intervention

Drug:
• ceftriaxone
Eligible infants will receive ceftriaxone as standard of care for sepsis

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in bilirubin binding assays		baseline and through study completion, an average of 1 hour
Secondary	Automated brain stem evoke response test		through study completion, an average of 1 hour