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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03133637
Other study ID # 29287
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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