CEFT: Ceftriaxone and Jaundice in Neonates

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT03133637
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaundice and Sepsis in Neonates	Drug: ceftriaxone

Study Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Ceftriaxone on Neonatal Jaundice
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Ceftriaxone Arm	Drug: ceftriaxone; Eligible infants will receive ceftriaxone as standard of care for sepsis

Outcome Measures

Primary Outcome Measures

1. change in bilirubin binding assays [baseline and through study completion, an average of 1 hour]

Secondary Outcome Measures

1. Automated brain stem evoke response test [through study completion, an average of 1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Days to 7 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Rochester
• ClinicalTrials.gov Identifier: NCT03133637
• Other Study ID Numbers: 29287
• First Posted: Apr 28, 2017
• Last Update Posted: Apr 6, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Jaundice; Ceftriaxone

Study Results

No Results Posted as of Apr 6, 2021