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Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator

Primary Purpose

Early-Onset Sepsis, Neonatal, EOS

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
EOS calculator
Sponsored by
prof. dr. Frans B. Plötz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Onset Sepsis, Neonatal focused on measuring early-onset sepsis, neonatal, EOS calculator

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • postmenstrual age of 34 weeks or more;
  • age between 0-24 hours;
  • at least one EOS risk factor or clinical sign of infection (suspected of EOS) present within the first 24 hours of life;
  • parental/guardian consent.

Exclusion Criteria:

  • major congenital anomalies;
  • language barrier (lack of effective communication or whenever it hinders understanding).

Sites / Locations

  • Northwest ClinicsRecruiting
  • FlevoHospitalRecruiting
  • Amstelland HospitalRecruiting
  • OLVGRecruiting
  • Martini HospitalRecruiting
  • Spaarne HospitalRecruiting
  • Dijklander HospitalRecruiting
  • Canisius-Wilhelmina HospitalRecruiting
  • Máxima Medical CenterRecruiting
  • Zaans Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

NVK Guidelines

EOS Calculator

Arm Description

The NVK guidelines use 8 maternal and 15 neonatal risk factors, each categorized as either red flag or non-red flag. These criteria guide clinicians on the management in case of suspected EOS. Briefly, antibiotic treatment is recommended if at least one red flag and, or, two or more non-red flags are present. An observation period of at least 12 hours is recommended if one non-red flag is present. Antibiotics are recommended when an infection is suspected during this observation. Newborns without EOS risk factors, with a good clinical condition, and a gestational age of more than 36 weeks will be discharged. If the guidelines recommend an observation period, the newborn with a good clinical condition is discharged after repeating physical examination. In case antibiotic treatment is started, discharge depends on the duration of treatment and the clinical course. At discharge, parents are instructed to call the hospital in case of signs of infection within the first 14 days of life.

Using the EOS calculator application between 0-24 hours after birth, maternal EOS risk factors combined with the physical examination of the newborn are used to assign a risk category and accompanying clinical recommendation based on estimated EOS incidence for each newborn at-risk for an infection. The EOS calculator results are used to guide clinical management on performing either a diagnostic work-up and start of antibiotics for (suspected) EOS, or a conservative approach with routine controls of vital parameters every 3 hours. In case of routine controls, re-evaluation of physical appearance by a pediatric resident or pediatrician will take place within 24 hours postpartum. Newborns will be observed for at least 24 hours. In case antibiotics are started, the need for further treatment is depending on blood culture results, infection parameters, and clinical condition of the newborn. Discontinuation of antibiotics and discharge is at the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Co-primary superiority outcome: antibiotic therapy started within 24 hours after birth
The proportion of patients that started antibiotic therapy for suspected and, or proven EOS in the first 24 hours after birth.
First co-primary non-inferiority outcome (safety): proportion of patients with respiratory support
A composite non-inferiority outcome regarding the presence of one or more of the following four predefined safety criteria, namely 1) the need for any respiratory support, and/or 2) the need for an intravascular fluid bolus for hemodynamic instability due to sepsis, and/or 3) referral to a Neonatal Intensive Care Unit (NICU) for sepsis treatment, and/or 4) proven EOS. - Respiratory support is defined as any form of respiratory support (invasive ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula (HFNC), low flow oxygen) during the first week of life.
Second co-primary non-inferiority outcome (safety): proportion of patients with hemodynamic support
- Intravascular fluid bolus is defined as the intravenous administration of a fluid bolus of 10ml/kg within 15-30 minutes. It is the first step in the treatment of hemodynamically unstable newborns due to sepsis.
Third co-primary non-inferiority outcome (safety): proportion of patients referred to a NICU for sepsis treatment
Fourth co-primary non-inferiority outcome (safety): proportion of patients with proven EOS
- Proven EOS is defined as a blood or cerebrospinal fluid (CSF) culture obtained within 72 hours after birth growing a pathogenic bacterial species.

Secondary Outcome Measures

Duration of antibiotic therapy
The total duration of antibiotic therapy: date and time of first administration of intravenous antibiotic therapy, and date and time of the last administration of intravenous antibiotic therapy.
Antibiotic therapy started between 24-72 hours after birth
The proportion of antibiotic therapy started for suspected and, or proven EOS if symptoms started between 24-72 hours after birth.
Questionnaire: quality of life
To get an impression of the impact of (suspected) early-onset sepsis on the quality of life (QoL) of both parents/guardians and their child, parents/guardians will be asked to fill in a questionnaire on day 14 after birth. The first part collects information on medical factors after hospitalization (side effects, number of medical visits, readmission, and medication use) and basic needs of the newborn (sleep quality of the patient, (breast)feeding success rate). The second part addresses the subjective parental/guardian evaluation of the impact of newborns' admission, and parental/guardian projection of future QoL of their newborn. Statements with six possible answers will be used: 'not at all, a little, on average, more than average, a lot, not applicable' or 'poor, fair, good, very good, excellent, not applicable'. Participants will not score on a numbered scale but tick the answer (in text) that apply best. The last part of the questionnaire collects demographic data.

Full Information

First Posted
February 28, 2022
Last Updated
November 9, 2022
Sponsor
prof. dr. Frans B. Plötz
Collaborators
Dutch Society of Pediatrics, Zorgevaluatie Nederland, Care4Neo, everywhereIM
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1. Study Identification

Unique Protocol Identification Number
NCT05274776
Brief Title
Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator
Official Title
Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator: a Cluster Randomized Study (EOS Calculator RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
prof. dr. Frans B. Plötz
Collaborators
Dutch Society of Pediatrics, Zorgevaluatie Nederland, Care4Neo, everywhereIM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Newborns are at risk for early-onset sepsis (EOS), which occurs within 72 hours after birth. The incidence of proven EOS is 0.5-2.0 per 1000 live births. The annual birth rate in the Netherlands is around 170.000, consequently the number of EOS cases varies between 85 to 340. However, about 5%, thus 8500, of late preterm and term newborns receive empiric antibiotic therapy in compliance with the current Dutch guideline. An alternative is the CE certified EOS calculator application, which calculates an individual EOS risk with treatment advice. In this prospective cluster-randomized multicenter trial the current Dutch guideline will be compared with the EOS calculator in newborns at risk for EOS. The primary objectives of this study are: To investigate whether the use of the EOS calculator reduces antibiotic exposure in newborns with suspected EOS in the first 24 hours after birth. To investigate the presence of one or more of the following four predefined safety criteria, namely 1) the need for any respiratory support, and/or 2) the need for an intravascular fluid bolus for hemodynamic instability due to sepsis, and/or 3) referral to a Neonatal Intensive Care Unit for sepsis treatment, and/or 4) proven EOS. Secondary objectives of the study are: To investigate if the use of the EOS calculator decreases the total duration of antibiotic therapy in newborns with suspected EOS. To investigate if the use of the EOS calculator decreases the percentage of antibiotic therapy started for suspected and, or proven EOS if symptoms started between 24-72 hours after birth. To study the impact of (suspected) EOS on parents/guardians.
Detailed Description
Suspicion of EOS is often based on risk factors and nonspecific clinical symptoms, such as maternal fever during labor or rapid breathing in the newborn. The combination of the difficulty to recognize EOS in time and the risk of serious consequences of EOS not treated timely has resulted in a low threshold for the start of empirical antibiotic therapy. This has led to significant overtreatment. The current standard of care in the Netherlands is the Dutch Society of the Nederlands (NVK) guideline "Prevention and treatment of early-onset neonatal infections", which is an adaptation of the 2012 version of the National Institute for Health and Care Excellence (NICE) guideline "Antibiotics for early-onset neonatal infection: antibiotics for the prevention and treatment of early-onset neonatal infection". The NVK guideline uses risk factors and symptoms to categorically indicate which newborns need antibiotic therapy. Evaluating its use in 9 Dutch hospitals, limited adherence was found, especially when antibiotics were recommended by the guideline but withheld by the clinicians. This limited adherence indicates that it is desirable to amend the current guideline or to investigate the use of an alternative method. A new method for determining which newborns need antibiotic therapy is the "EOS calculator". Developed in the United States, this method uses a combination of detailed information about 5 maternal risk factors and the presence of clinical neonatal symptoms to calculate an individual EOS risk and treatment advice. For the Dutch situation, equipoise between the current NVK guideline and the EOS calculator can be established given balance of risk for both over- and undertreatment of EOS for both strategies. A large body of evidence now supports the safety of the EOS calculator approach, but validation outside of the North-American setting is limited, especially for safety outcomes. A prospective cluster-randomized Dutch validation study of the EOS calculator is needed before implementation because of the following reasons: Multicenter validation of actual EOS calculator use has not been performed in the Netherlands. To date, no randomized prospective study of EOS calculator use with safety as an outcome measure has been performed. Specifically, there are no studies that take into account the potential effects of a treatment delay due to EOS calculator use. This especially holds true for cases that are clinically suspect for EOS, but not culture-confirmed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Onset Sepsis, Neonatal, EOS
Keywords
early-onset sepsis, neonatal, EOS calculator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, cluster-randomized trial will be conducted; five hospitals will be randomized to NVK guidelines use, five hospitals will be randomized to EOS calculator use. After randomization, the assigned protocol is considered standard care for newborns with suspected EOS within 0-24 hours after birth during the study period in that hospital. This means that the NVK guidelines or the EOS calculator (depending on randomization) will be used for all newborns at risk for EOS (within 0-24 hours after birth) in the assigned hospital, independent of study participation. It is noteworthy that attending physicians have the option to choose for clinical management according to another protocol instead of the assigned protocol.
Masking
None (Open Label)
Masking Description
Hospitals nor physicians are blinded for the assigned study protocol. Since the assigned protocol is considered standard care for newborns with suspected EOS within 0-24 hours after birth during the study period in that hospital, independent of study participation, parents of participants are not blinded as well.
Allocation
Randomized
Enrollment
1830 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NVK Guidelines
Arm Type
No Intervention
Arm Description
The NVK guidelines use 8 maternal and 15 neonatal risk factors, each categorized as either red flag or non-red flag. These criteria guide clinicians on the management in case of suspected EOS. Briefly, antibiotic treatment is recommended if at least one red flag and, or, two or more non-red flags are present. An observation period of at least 12 hours is recommended if one non-red flag is present. Antibiotics are recommended when an infection is suspected during this observation. Newborns without EOS risk factors, with a good clinical condition, and a gestational age of more than 36 weeks will be discharged. If the guidelines recommend an observation period, the newborn with a good clinical condition is discharged after repeating physical examination. In case antibiotic treatment is started, discharge depends on the duration of treatment and the clinical course. At discharge, parents are instructed to call the hospital in case of signs of infection within the first 14 days of life.
Arm Title
EOS Calculator
Arm Type
Experimental
Arm Description
Using the EOS calculator application between 0-24 hours after birth, maternal EOS risk factors combined with the physical examination of the newborn are used to assign a risk category and accompanying clinical recommendation based on estimated EOS incidence for each newborn at-risk for an infection. The EOS calculator results are used to guide clinical management on performing either a diagnostic work-up and start of antibiotics for (suspected) EOS, or a conservative approach with routine controls of vital parameters every 3 hours. In case of routine controls, re-evaluation of physical appearance by a pediatric resident or pediatrician will take place within 24 hours postpartum. Newborns will be observed for at least 24 hours. In case antibiotics are started, the need for further treatment is depending on blood culture results, infection parameters, and clinical condition of the newborn. Discontinuation of antibiotics and discharge is at the discretion of the treating physician.
Intervention Type
Device
Intervention Name(s)
EOS calculator
Other Intervention Name(s)
early-onset sepsis calculator, neonatal early-onset sepsis calculator, sepsis risk calculator (SRC), newborn sepsis calculator, neonatal EOS calculator
Intervention Description
For this study the EOS calculator was developed as a mobile application (by everywhereIM), including CE marking. It is concerned a medical device for health care professionals.
Primary Outcome Measure Information:
Title
Co-primary superiority outcome: antibiotic therapy started within 24 hours after birth
Description
The proportion of patients that started antibiotic therapy for suspected and, or proven EOS in the first 24 hours after birth.
Time Frame
0-24 hours after birth
Title
First co-primary non-inferiority outcome (safety): proportion of patients with respiratory support
Description
A composite non-inferiority outcome regarding the presence of one or more of the following four predefined safety criteria, namely 1) the need for any respiratory support, and/or 2) the need for an intravascular fluid bolus for hemodynamic instability due to sepsis, and/or 3) referral to a Neonatal Intensive Care Unit (NICU) for sepsis treatment, and/or 4) proven EOS. - Respiratory support is defined as any form of respiratory support (invasive ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula (HFNC), low flow oxygen) during the first week of life.
Time Frame
0-14 days after birth
Title
Second co-primary non-inferiority outcome (safety): proportion of patients with hemodynamic support
Description
- Intravascular fluid bolus is defined as the intravenous administration of a fluid bolus of 10ml/kg within 15-30 minutes. It is the first step in the treatment of hemodynamically unstable newborns due to sepsis.
Time Frame
0-14 days after birth
Title
Third co-primary non-inferiority outcome (safety): proportion of patients referred to a NICU for sepsis treatment
Time Frame
0-14 days after birth
Title
Fourth co-primary non-inferiority outcome (safety): proportion of patients with proven EOS
Description
- Proven EOS is defined as a blood or cerebrospinal fluid (CSF) culture obtained within 72 hours after birth growing a pathogenic bacterial species.
Time Frame
0-14 days after birth
Secondary Outcome Measure Information:
Title
Duration of antibiotic therapy
Description
The total duration of antibiotic therapy: date and time of first administration of intravenous antibiotic therapy, and date and time of the last administration of intravenous antibiotic therapy.
Time Frame
0-14 days after birth
Title
Antibiotic therapy started between 24-72 hours after birth
Description
The proportion of antibiotic therapy started for suspected and, or proven EOS if symptoms started between 24-72 hours after birth.
Time Frame
24-72 hours after birth
Title
Questionnaire: quality of life
Description
To get an impression of the impact of (suspected) early-onset sepsis on the quality of life (QoL) of both parents/guardians and their child, parents/guardians will be asked to fill in a questionnaire on day 14 after birth. The first part collects information on medical factors after hospitalization (side effects, number of medical visits, readmission, and medication use) and basic needs of the newborn (sleep quality of the patient, (breast)feeding success rate). The second part addresses the subjective parental/guardian evaluation of the impact of newborns' admission, and parental/guardian projection of future QoL of their newborn. Statements with six possible answers will be used: 'not at all, a little, on average, more than average, a lot, not applicable' or 'poor, fair, good, very good, excellent, not applicable'. Participants will not score on a numbered scale but tick the answer (in text) that apply best. The last part of the questionnaire collects demographic data.
Time Frame
14-28 days after birth

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: postmenstrual age of 34 weeks or more; age between 0-24 hours; at least one EOS risk factor or clinical sign of infection (suspected of EOS) present within the first 24 hours of life; parental/guardian consent. Exclusion Criteria: major congenital anomalies; language barrier (lack of effective communication or whenever it hinders understanding).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Frans B. Plötz, MD, PhD
Phone
+31(0)887531753
Email
fbplotz@tergooi.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Bo M. van der Weijden, MD
Email
b.m.vanderweijden@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans B. Plötz, MD, PhD
Organizational Affiliation
Amsterdam UMC, Tergooi Ziekenhuizen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niek B. Achten, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo M. van der Weijden, MD
Organizational Affiliation
Amsterdam UMC, Tergooi Ziekenhuizen
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Clinics
City
Alkmaar
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
FlevoHospital
City
Almere
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amstelland Hospital
City
Amstelveen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Martini Hospital
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Spaarne Hospital
City
Haarlem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Dijklander Hospital
City
Hoorn
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina Hospital
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Máxima Medical Center
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Zaans Medical Centre
City
Zaandam
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available on request through a repository and shared after consent of the principal investigator.
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