Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04470596
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2020-07-09
Brief Title:
Clinical Evaluation of Early Onset Neonatal Infection
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Clinical Evaluation of Early Onset Neonatal Infection
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEEONI
Brief 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 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 04 1000 is lower than in other developed countries 08 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None