NCT03133637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3.5 years

First QC Date

March 30, 2017

Last Update Submit

April 5, 2021

Conditions

Jaundice and Sepsis in Neonates

Outcome Measures

Primary Outcomes (1)

  • change in bilirubin binding assays

    baseline and through study completion, an average of 1 hour

Secondary Outcomes (1)

  • Automated brain stem evoke response test

    through study completion, an average of 1 hour

Study Arms (1)

Ceftriaxone Arm

Drug: ceftriaxone

Interventions

ceftriaxoneDRUG

Eligible infants will receive ceftriaxone as standard of care for sepsis

Ceftriaxone Arm

Eligibility Criteria

Age3 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term neonates

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Jaundice

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 28, 2017

Study Start

March 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

US(1)