Skip to main content
OpenTrials
Completed

NCT Number: NCT03133637

Ceftriaxone and Jaundice in Neonates

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Jaundice and Sepsis in Neonates Hyperbilirubinemia Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

3 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftriaxone

Drug

Eligible infants will receive ceftriaxone as standard of care for sepsis

Primary outcomes

  1. change in bilirubin binding assays

    Time frame: baseline and through study completion, an average of 1 hour

Secondary outcomes

  1. Automated brain stem evoke response test

    Time frame: through study completion, an average of 1 hour

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Effect of Ceftriaxone on Neonatal Jaundice

Acronym: CEFT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.