NewbornCLEEONINCT04470596
Clinical Evaluation of Early Onset Neonatal Infection
An observational study of Newborn, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries. Read more about this study
- Who is it for?
- Ages 36 weeks and older
- Conditions the study is for
- Newborn
- How many people
- 936 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2020to 31 Dec 2021
- 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 36 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Newborns over 36 weeks old, born between 01/01/2019 and 31/12/2019 at the GHPSJ maternity, having benefited from close infectious surveillance according to the criteria of the 2017 recommendations (Groups B and C).
Who may be able to join
- Newborns over 36 weeks old, born between 01/01/2019 and 31/12/2019 at the GHPSJ maternity
- Newborn having benefited from close infectious surveillance according to the criteria of the 2017 recommendations (Groups B and C)
- In birth suites near their mother
- Francophone parents
Who cannot join
- Parents objecting to participation in the study
- Parents deprived of their liberty
- Parents under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries. The germs most frequently found are Streptococcus B (SB) for term newborns (> 37 Weeks of Amenorrhea SA) and Escherichia coli (E. coli) in premature newborns. Although in France, its incidence of 0.4 / 1000 is lower than in other developed countries (0.8 / 1000 general incidence), it remains a major public health concern.
The infection criteria were defined by the National Agency for Health Accreditation and Assessment (ANAES) in 2002, allowing to differentiate between proven infections and highly probable cases of infection. Infection is considered to be proven when SB or E. coli is detected in blood culture or in cerebrospinal fluid. An infection is considered to be highly probable in the event of association of clinical signs (fever, polypnea, desaturation, tachycardia, etc.) evoking a beginning sepsis associating with a disturbance of the biological balance sheet (elevation of CRP, hyperleukocytosis, evidence of colonization on peripheral samples). These criteria remain valid to this day to define the infection.
Read more
In order to define the newborns to be monitored, risk factors were established after a review of the literature in 2002. They make it possible to decide on diagnostic management and / or the setting up of a treatment.
Since the recommendations of the ANAES of 2002, the rule, from the presence of a major criterion, was to carry out bacteriological samples peripheral to the birth (gastric liquid, swab of ear and anus) and to systematically collect a CRP of the child between H12 and H48. In the presence of an isolated minor risk factor, simple clinical monitoring (routine) was recommended for 48 hours without deciding firmly on the need for a biological sample. However, it is important to note that these two categories of signs are defined and classified in descending order of risk. This classification does not prejudge a systematic therapeutic attitude. In many situations, the choice is actually left to the practitioner depending on the context.
In 2017, new recommendations were implemented by the French Society of Pediatrics (SFP) and the French Society of Neonatology (SFN) regarding the prevention of INBP. These take up the risk factors of the 2002 ANAES by adding PCR SB at the same level as the traditional PV. They define 3 categories of children according to the risk of INBP and the associated care.
In most cases, these new practices make it possible to dispense with costly blood and bacteriological samples, which cause discomfort and pain for children. In addition, the use of gastric fluid is not internationally validated, its use in the management case remains very controversial. In case of delayed CRP or positive peripheral samples to the germs generated, and even in the absence of clinical signs, antibiotic therapy was almost systematically initiated. Unnecessary exposure to antibiotics promotes the development of bacteriological resistance and unbalances the neonatal flora.
Following the implementation of these new recommendations at the Notre Dame de Bon Secours maternity hospital, which is the case in few centers today and no national survey has yet been carried out on their application, it therefore seems necessary to us evaluate the application of these new recommendations and verify that they allow the detection of all probable or proven infections.
- Conditions
- Newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn screening
This outcome corresponds to percentage of asymptomatic infants at risk for INBP in whom close clinical surveillance has shown no signs of infectious disease, and who have had a probable or proven infection between the discharge from maternity and the age of 1 and 3 months.
Measured: Month 3
Secondary outcomes (1)
negative predictive value of SB PCR for children with proven group B Streptococcus infection
This outcome corresponds to percentage of newborns infected with group B Streptococcus (proven infection) during the postnatal stay and whose mothers' PCRs were negative per partum, whether or not they were monitored.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start9 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies 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
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth WALTER, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470596
- Sponsor's protocol ID
- CLEEONI
- Acronym
- CLEEONI
- Status last verified
- Dec 2021
- First submitted
- 9 Jul 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weston EJ, Pondo T, Lewis MM, Martell-Cleary P, Morin C, Jewell B, Daily P, Apostol M, Petit S, Farley M, Lynfield R, Reingold A, Hansen NI, Stoll BJ, Shane AL, Zell E, Schrag SJ. The burden of invasive early-onset neonatal sepsis in the United States, 2005-2008. Pediatr Infect Dis J. 2011 Nov;30(11):937-41. doi: 10.1097/INF.0b013e318223bad2.
PubMed 21654548Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
PubMed 21518717El Helali N, Nguyen JC, Ly A, Giovangrandi Y, Trinquart L. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis. 2009 Aug 1;49(3):417-23. doi: 10.1086/600303.
PubMed 19580414
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Early Onset Neonatal Infection
- ClinicalTrials.gov ID
- NCT04470596
- Acronym / sponsor ID
- CLEEONI / CLEEONI
- Conditions
- Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 9 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jul 2020 (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.
Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries. The germs most frequently found are Streptococcus B (SB) for term newborns (> 37 Weeks of Amenorrhea SA) and Escherichia coli (E. coli) in premature newborns. Although in France, its incidence of 0.4 / 1000 is lower than in other developed countries (0.8 / 1000 general incidence), it remains a major public health concern.
The infection criteria were defined by the National Agency for Health Accreditation and Assessment (ANAES) in 2002, allowing to differentiate between proven infections and highly probable cases of infection. Infection is considered to be proven when SB or E. coli is detected in blood culture or in cerebrospinal fluid. An infection is considered to be highly probable in the event of association of clinical signs (fever, polypnea, desaturation, tachycardia, etc.) evoking a beginning sepsis associating with a disturbance of the biological balance sheet (elevation of CRP, hyperleukocytosis, evidence of colonization on peripheral samples). These criteria remain valid to this day to define the infection.
In order to define the newborns to be monitored, risk factors were established after a review of the literature in 2002. They make it possible to decide on diagnostic management and / or the setting up of a treatment.
Since the recommendations of the ANAES of 2002, the rule, from the presence of a major criterion, was to carry out bacteriological samples peripheral to the birth (gastric liquid, swab of ear and anus) and to systematically collect a CRP of the child between H12 and H48. In the presence of an isolated minor risk factor, simple clinical monitoring (routine) was recommended for 48 hours without deciding firmly on the need for a biological sample. However, it is important to note that these two categories of signs are defined and classified in descending order of risk. This classification does not prejudge a systematic therapeutic attitude. In many situations, the choice is actually left to the practitioner depending on the context.
In 2017, new recommendations were implemented by the French Society of Pediatrics (SFP) and the French Society of Neonatology (SFN) regarding the prevention of INBP. These take up the risk factors of the 2002 ANAES by adding PCR SB at the same level as the traditional PV. They define 3 categories of children according to the risk of INBP and the associated care.
In most cases, these new practices make it possible to dispense with costly blood and bacteriological samples, which cause discomfort and pain for children. In addition, the use of gastric fluid is not internationally validated, its use in the management case remains very controversial. In case of delayed CRP or positive peripheral samples to the germs generated, and even in the absence of clinical signs, antibiotic therapy was almost systematically initiated. Unnecessary exposure to antibiotics promotes the development of bacteriological resistance and unbalances the neonatal flora.
Following the implementation of these new recommendations at the Notre Dame de Bon Secours maternity hospital, which is the case in few centers today and no national survey has yet been carried out on their application, it therefore seems necessary to us evaluate the application of these new recommendations and verify that they allow the detection of all probable or proven infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 36 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Newborns over 36 weeks old, born between 01/01/2019 and 31/12/2019 at the GHPSJ maternity, having benefited from close infectious surveillance according to the criteria of the 2017 recommendations (Groups B and C).
Key inclusion criteria (4 listed)
- Newborns over 36 weeks old, born between 01/01/2019 and 31/12/2019 at the GHPSJ maternity
- Newborn having benefited from close infectious surveillance according to the criteria of the 2017 recommendations (Groups B and C)
- In birth suites near their mother
- Francophone parents
Key exclusion criteria (3 listed)
- Parents objecting to participation in the study
- Parents deprived of their liberty
- Parents under guardianship or curatorship
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
Newborn screening
Time frame: Month 3
This outcome corresponds to percentage of asymptomatic infants at risk for INBP in whom close clinical surveillance has shown no signs of infectious disease, and who have had a probable or proven infection between the discharge from maternity and the age of 1 and 3 months.
1 secondary outcome
negative predictive value of SB PCR for children with proven group B Streptococcus infection
Time frame: Month 3
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 4 Jan 2022.
- Results publication: PubMed 21654548Weston EJ, Pondo T, Lewis MM, Martell-Cleary P, Morin C, Jewell B, Daily P, Apostol M, Petit S, Farley M, Lynfield R, Reingold A, Hansen NI, Stoll BJ, Shane AL, Zell E, Schrag SJ. The burden of invasive early-onset neonatal sepsis in the United States, 2005-2008. Pediatr Infect Dis J. 2011 Nov;30(11):937-41. doi: 10.1097/INF.0b013e318223bad2.
- Results publication: PubMed 21518717Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
- Results publication: PubMed 19580414El Helali N, Nguyen JC, Ly A, Giovangrandi Y, Trinquart L. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis. 2009 Aug 1;49(3):417-23. doi: 10.1086/600303.
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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.
Elizabeth WALTER, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Newborn, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 4 Jan 2022. 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 France. 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?
Newborn screening (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470596, which also lists 3 linked publications.
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 4 Jan 2022.