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NewbornCLEEONINCT04470596

Clinical Evaluation of Early Onset Neonatal Infection

An observational study of Newborn, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

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.

  1. 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)
  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.

  1. First posted14 Jul 2020
  2. Study start9 Aug 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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)
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 21654548
  • Stoll 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 21518717
  • El 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

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.

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