Neonatal SepsisNCT02061150
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
An observational study of Neonatal Sepsis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Neonatal Sepsis
- How many people
- 800 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Jun 2015
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Study population: Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,
Who may be able to join
- Term newborns with blood cultures taken from them the first 48 hrs
Who cannot join
- Preterm newborns
- Septic/ill appearing newborns
- Newborns requiring admission to NICU
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Hillel Yaffe Medical Center
Hadera, 38100
Amit Hochberg, MD, +972-4-6304320, amith@hy.health.gov.il
Amit Hochberg, MD
About this study
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.
- Conditions
- Neonatal Sepsis
- Keywords
- Early onset GBS sepsis, Prevention, Maternal risk factors
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic newborns that had sepsis workup | Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic newborns that underwent sepsis workup
The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined
Measured: 3 years
Secondary outcomes (1)
Positive blood cultures out of total cultures
Percentage of positive blood cultures out of the total cultures that were taken.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies 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
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061150
- Sponsor's protocol ID
- HYMC-104-13
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
- ClinicalTrials.gov ID
- NCT02061150
- Acronym / sponsor ID
- HYMC-104-13
- Conditions
- Neonatal Sepsis
- Keywords
- Early onset GBS sepsis, Prevention, Maternal risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- 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.
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic newborns that had sepsis workup | – | –Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,
Key inclusion criteria (1 listed)
- Term newborns with blood cultures taken from them the first 48 hrs
Key exclusion criteria (3 listed)
- Preterm newborns
- Septic/ill appearing newborns
- Newborns requiring admission to NICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asymptomatic newborns that underwent sepsis workup
Time frame: 3 years
The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined
1 secondary outcome
Positive blood cultures out of total cultures
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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.
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 Neonatal Sepsis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Hochberg, MD (+972-4-6304320, amith@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymptomatic newborns that underwent sepsis workup (time frame: 3 years). 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 12 Feb 2014.