Jaundice and Sepsis in NeonatesCEFTNCT03133637
Ceftriaxone and Jaundice in Neonates
An observational study of Jaundice and Sepsis in Neonates, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 days
- Conditions the study is for
- Jaundice and Sepsis in Neonates
- What is being tested?
- ceftriaxone
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Term neonates
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Effect of Ceftriaxone on Neonatal Jaundice
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.
- Conditions
- Jaundice and Sepsis in Neonates
- Being tested
- ceftriaxone
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
Eligible infants will receive ceftriaxone as standard of care for sepsis
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone Arm | Not described Receives: Drug: ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bilirubin binding assays
Measured: baseline and through study completion, an average of 1 hour
Secondary outcomes (1)
Automated brain stem evoke response test
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startMar 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice and Sepsis in NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133637
- Sponsor's protocol ID
- 29287
- Acronym
- CEFT
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2017
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ceftriaxone on Neonatal Jaundice
- ClinicalTrials.gov ID
- NCT03133637
- Acronym / sponsor ID
- CEFT / 29287
- Conditions
- Jaundice and Sepsis in Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone Arm | – | Drug: ceftriaxone |
Who may qualify
- Ages
- 3 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term neonates
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftriaxoneEligible infants will receive ceftriaxone as standard of care for sepsis | Drug | Ceftriaxone Arm |
Primary outcome
change in bilirubin binding assays
Time frame: baseline and through study completion, an average of 1 hour
1 secondary outcome
Automated brain stem evoke response test
Time frame: through study completion, an average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice and Sepsis in Neonates, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in bilirubin binding assays (time frame: baseline and through study completion, an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.