Critical IllnessNCT04876872
Modified Pediatric Early Warning Score and Modified PRISA II During COVID-19 Pandemic
An observational study of Critical Illness, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
One of the most important factors in pediatric emergency units is the correct decision of the patient inpatient or outpatient treatment. If the disease progresses critically, the decision of hospitalization comes to the fore. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Critical Illness
- How many people
- 894 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 15 Sep 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients aged between 28 days and 18 years who applied to the Pediatric Emergency Unit
Who may be able to join
- Pediatric patients aged between 28 days and 18 years, who applied to the Pediatric Emergency Unit
Who cannot join
- In the follow-up or at the begining, patients who are presenting with cardiorespiratory arrest
- Intubated patients,
- Trauma patients
- Neonatal period (<28 days),
- Patients who leave the hospital at the request of their family before the end of the diagnosis or treatment process
- Patients who do not have permission from their parents at the beginning
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karadeniz Technical University Faculty of Medicine Farabi Hospital
Trabzon, 9061080
AHMET K ÖZKAYA, +90 05554093361, kaganozkaya@yahoo.com
Bihter Şen Şahin, +90 05389473100, bihtersen@hotmail.com
About this study
Official title: The Effectiveness of Modified Pediatric Early Warning Score and Pediatric Hospitalization Risk Scoring II in Patients Applying to the Pediatric Emergency Unit During Pandemic Period Associated With COVID-19 Disease
One of the most important factors in pediatric emergency units is the correct decision of the patient inpatient or outpatient treatment.
If the disease progresses critically, the decision of hospitalization comes to the fore. However, in this case, it is very important to make the right decision and to determine the situation in a short time.
Read more
Children give different physiological responses to diseases according to age group. For this reason, some scoring, which require objective parameters, have been developed in order to predict the critical processes of the patients and to intervene at the right time.
While such scoring is frequently used in adult emergency units, it is understood that studies on this issue are not sufficient in pediatric emergency units.
The purpose of our study; To evaluate the population of children admitted to the pediatric emergency unit with the modified Pediatric Early Warning Scoring (mPEUS) and Pediatric Hospitalization Risk Scoring II (PRISA II), to predict hospitalization and discharge from the emergency service, and to demonstrate the effectiveness of the scoring to identify critically ill children in the correct early period.
Read the detailed description
Triage is the primary step where the first treatment service of a patient admitted to the emergency unit is initiated.
The purpose of triage in the emergency room is a rapid assessment to determine the order of priority. Emergency service triage systems have been developed mainly to identify the "most urgent" or potentially "critical pediatric" cases and give priority to treatment for these patients.
If the patient's condition is critical in the pediatric emergency unit, the decision for outpatient treatment / hospitalization should be made quickly but in the most correct way. Regardless of the diagnosis, the main problem is; early diagnosis of the critical patient, directing the patient to the appropriate area in the emergency department for acute stabilization, and more importantly, to decide quickly whether the patient will be hospitalized in order to continue the treatment and accelerate the flow of the emergency service. It is known that children who unexpectedly worsen in the hospital environment will have observable features in the period before the seriousness of their condition is understood. It has been emphasized in the studies conducted that ways to understand early whether there is a problem in a child should be investigated. For this reason, some scores that require objective parameters have been developed in order to predict the critical processes of the patients and to intervene at the right time. These scores should be viewed not only as a score, but as a complementary systematic approach used to improve pediatric patient safety and clinical outcomes. mPEUS; These are physiology-based scoring systems developed to identify patients with clinical worsening. Studies have reported that with these scores, the treatment of critical emergency patients can be started without delay. mPEUS has been developed to provide a reproducible assessment of the pediatric patient's condition based on physiological parameters. In addition, the use of these scores in the emergency service and inpatient services ensures continuity in patient evaluation. To date, there are very few data regarding the use of mPEUS in children presenting to the emergency department. Although many mPEUS have been developed and tested, uncertainty remains as to which system or system feature is most beneficial for pediatric patients. Therefore, studies on this subject should be increased. mPEUS is an essential tool for patient safety. The use of mPEUS during the initial evaluation can help prevent poor neurological results, deterioration of the patient's condition, and reduce mortality with rapid intervention. In limited studies conducted in pediatric emergency units, it has been shown that these early warning scores can determine the children who need to be admitted to the Pediatric Intensive Care Unit (PICU). With this scoring, the early hospitalization of the patient in the emergency room can be accurately predicted. Such early warning scoring can be used to shorten patients' hospitalization and waiting times in emergency rooms. The PRISA II system, similar to mPEUS but used only to predict inpatients, has also been developed. This scale includes initial history, physiological parameters, chronic disease status, treatments applied in the emergency department and laboratory values. It is appropriate to use PRISA II to control the severity of the disease. There is not enough data in the literature regarding the efficacy of both mPEUS and PRISA II scoring in the epidemic period associated with COVID-19. With this study, it is aimed to provide efficiency by using these scoring in patients who applied to the pediatric emergency unit during the pandemic period.
- Conditions
- Critical Illness
- Being tested
- no intervention
- Keywords
- critically ill child, pediatric early warning score, mPEWS, mPRISA II
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients | whole pediatric patients who admitted to the pediatric emergency unit in Farabi Hospital, Trabzon, Turkey Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified pediatric early warning score
modified pediatric early warning score for each child during Severe Acute Respiratory Syndrome Causing Coronavirus Disease
Measured: 1 February - 31 July 2021,
mPRISA II
mPRISA II score for each child during COVID-19 pandemic
Measured: 1 February - 31 July 2021
Changes in modified pediatric early warning score over time
Changes in modified pediatric early warning score over time will measure. Early warning score will be calculated every three hours and if the score increases, it will be evaluated more frequently, up to 24 hours.
Measured: 1 February - 31 July 2021
Secondary outcomes (6)
Length of stay in pediatric emergency
Length of stay in pediatric emergency
Measured: 1 February - 31 July 2021
number of children who returned to the emergency service
number of children who returned to the emergency service
Measured: 1 February - 31 July 2021
which service is admitted to
pediatric wards
Measured: 1 February - 31 July 2021
number of children with severe acute respiratory syndrome coronavirus 2
Children diagnosed with COVID-19 (real time PCR positive children)
Measured: 1 February - 31 July 2021
children who contacted the person with COVID-19
number and status of children who contacted the person with COVID-19
Measured: 1 February - 31 July 2021
history of COVID-19 in the past
number of children who had COVID-19 in the past
Measured: 1 February - 31 July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Feb 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 894 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Kagan Ozkaya, Karadeniz Technical University
- Investigators
- Ahmet K Özkaya, MD, phD, Study director, Karadeniz Technical University Faculty of MedicineBihter Şen Şahin, MD, Principal investigator, Karadeniz Technical University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876872
- Sponsor's protocol ID
- KTU-PediEM01
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamberlain JM, Patel KM, Pollack MM. The Pediatric Risk of Hospital Admission score: a second-generation severity-of-illness score for pediatric emergency patients. Pediatrics. 2005 Feb;115(2):388-95. doi: 10.1542/peds.2004-0586.
PubMed 15687449Lambert V, Matthews A, MacDonell R, Fitzsimons J. Paediatric early warning systems for detecting and responding to clinical deterioration in children: a systematic review. BMJ Open. 2017 Mar 13;7(3):e014497. doi: 10.1136/bmjopen-2016-014497.
PubMed 28289051Jagt EW. Improving Pediatric Survival from Resuscitation Events: The Role and Organization of Hospital-based Rapid Response Systems and Code Teams. Curr Pediatr Rev. 2013;9(2):158-74. doi: 10.2174/1573396311309020009.
PubMed 25417037Skaletzky SM, Raszynski A, Totapally BR. Validation of a modified pediatric early warning system score: a retrospective case-control study. Clin Pediatr (Phila). 2012 May;51(5):431-5. doi: 10.1177/0009922811430342. Epub 2011 Dec 8.
PubMed 22157421Egdell P, Finlay L, Pedley DK. The PAWS score: validation of an early warning scoring system for the initial assessment of children in the emergency department. Emerg Med J. 2008 Nov;25(11):745-9. doi: 10.1136/emj.2007.054965.
PubMed 18955610Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785.
PubMed 28557729
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Modified Pediatric Early Warning Score and Pediatric Hospitalization Risk Scoring II in Patients Applying to the Pediatric Emergency Unit During Pandemic Period Associated With COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04876872
- Acronym / sponsor ID
- KTU-PediEM01
- Conditions
- Critical Illness
- Keywords
- critically ill child, pediatric early warning score, mPEWS, mPRISA II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 894 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 7 May 2021 (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.
One of the most important factors in pediatric emergency units is the correct decision of the patient inpatient or outpatient treatment.
If the disease progresses critically, the decision of hospitalization comes to the fore. However, in this case, it is very important to make the right decision and to determine the situation in a short time.
Children give different physiological responses to diseases according to age group. For this reason, some scoring, which require objective parameters, have been developed in order to predict the critical processes of the patients and to intervene at the right time.
While such scoring is frequently used in adult emergency units, it is understood that studies on this issue are not sufficient in pediatric emergency units.
The purpose of our study; To evaluate the population of children admitted to the pediatric emergency unit with the modified Pediatric Early Warning Scoring (mPEUS) and Pediatric Hospitalization Risk Scoring II (PRISA II), to predict hospitalization and discharge from the emergency service, and to demonstrate the effectiveness of the scoring to identify critically ill children in the correct early period.
Detailed description
Triage is the primary step where the first treatment service of a patient admitted to the emergency unit is initiated.
The purpose of triage in the emergency room is a rapid assessment to determine the order of priority. Emergency service triage systems have been developed mainly to identify the "most urgent" or potentially "critical pediatric" cases and give priority to treatment for these patients.
If the patient's condition is critical in the pediatric emergency unit, the decision for outpatient treatment / hospitalization should be made quickly but in the most correct way. Regardless of the diagnosis, the main problem is; early diagnosis of the critical patient, directing the patient to the appropriate area in the emergency department for acute stabilization, and more importantly, to decide quickly whether the patient will be hospitalized in order to continue the treatment and accelerate the flow of the emergency service. It is known that children who unexpectedly worsen in the hospital environment will have observable features in the period before the seriousness of their condition is understood. It has been emphasized in the studies conducted that ways to understand early whether there is a problem in a child should be investigated. For this reason, some scores that require objective parameters have been developed in order to predict the critical processes of the patients and to intervene at the right time. These scores should be viewed not only as a score, but as a complementary systematic approach used to improve pediatric patient safety and clinical outcomes. mPEUS; These are physiology-based scoring systems developed to identify patients with clinical worsening. Studies have reported that with these scores, the treatment of critical emergency patients can be started without delay. mPEUS has been developed to provide a reproducible assessment of the pediatric patient's condition based on physiological parameters. In addition, the use of these scores in the emergency service and inpatient services ensures continuity in patient evaluation. To date, there are very few data regarding the use of mPEUS in children presenting to the emergency department. Although many mPEUS have been developed and tested, uncertainty remains as to which system or system feature is most beneficial for pediatric patients. Therefore, studies on this subject should be increased. mPEUS is an essential tool for patient safety. The use of mPEUS during the initial evaluation can help prevent poor neurological results, deterioration of the patient's condition, and reduce mortality with rapid intervention. In limited studies conducted in pediatric emergency units, it has been shown that these early warning scores can determine the children who need to be admitted to the Pediatric Intensive Care Unit (PICU). With this scoring, the early hospitalization of the patient in the emergency room can be accurately predicted. Such early warning scoring can be used to shorten patients' hospitalization and waiting times in emergency rooms. The PRISA II system, similar to mPEUS but used only to predict inpatients, has also been developed. This scale includes initial history, physiological parameters, chronic disease status, treatments applied in the emergency department and laboratory values. It is appropriate to use PRISA II to control the severity of the disease. There is not enough data in the literature regarding the efficacy of both mPEUS and PRISA II scoring in the epidemic period associated with COVID-19. With this study, it is aimed to provide efficiency by using these scoring in patients who applied to the pediatric emergency unit during the pandemic period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients | – | Other: no interventionwhole pediatric patients who admitted to the pediatric emergency unit in Farabi Hospital, Trabzon, Turkey |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients aged between 28 days and 18 years who applied to the Pediatric Emergency Unit
Key inclusion criteria (1 listed)
- Pediatric patients aged between 28 days and 18 years, who applied to the Pediatric Emergency Unit
Key exclusion criteria (6 listed)
- In the follow-up or at the begining, patients who are presenting with cardiorespiratory arrest
- Intubated patients,
- Trauma patients
- Neonatal period (<28 days),
- Patients who leave the hospital at the request of their family before the end of the diagnosis or treatment process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | pediatric patients |
Primary outcome
modified pediatric early warning score
Time frame: 1 February - 31 July 2021,
modified pediatric early warning score for each child during Severe Acute Respiratory Syndrome Causing Coronavirus Disease
mPRISA II
Time frame: 1 February - 31 July 2021
mPRISA II score for each child during COVID-19 pandemic
Changes in modified pediatric early warning score over time
Time frame: 1 February - 31 July 2021
Changes in modified pediatric early warning score over time will measure. Early warning score will be calculated every three hours and if the score increases, it will be evaluated more frequently, up to 24 hours.
6 secondary outcomes
Length of stay in pediatric emergency
Time frame: 1 February - 31 July 2021
number of children who returned to the emergency service
Time frame: 1 February - 31 July 2021
which service is admitted to
Time frame: 1 February - 31 July 2021
number of children with severe acute respiratory syndrome coronavirus 2
Time frame: 1 February - 31 July 2021
children who contacted the person with COVID-19
Time frame: 1 February - 31 July 2021
history of COVID-19 in the past
Time frame: 1 February - 31 July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 15687449Chamberlain JM, Patel KM, Pollack MM. The Pediatric Risk of Hospital Admission score: a second-generation severity-of-illness score for pediatric emergency patients. Pediatrics. 2005 Feb;115(2):388-95. doi: 10.1542/peds.2004-0586.
- Results publication: PubMed 28289051Lambert V, Matthews A, MacDonell R, Fitzsimons J. Paediatric early warning systems for detecting and responding to clinical deterioration in children: a systematic review. BMJ Open. 2017 Mar 13;7(3):e014497. doi: 10.1136/bmjopen-2016-014497.
- Results publication: PubMed 25417037Jagt EW. Improving Pediatric Survival from Resuscitation Events: The Role and Organization of Hospital-based Rapid Response Systems and Code Teams. Curr Pediatr Rev. 2013;9(2):158-74. doi: 10.2174/1573396311309020009.
- Results publication: PubMed 22157421Skaletzky SM, Raszynski A, Totapally BR. Validation of a modified pediatric early warning system score: a retrospective case-control study. Clin Pediatr (Phila). 2012 May;51(5):431-5. doi: 10.1177/0009922811430342. Epub 2011 Dec 8.
- Results publication: PubMed 18955610Egdell P, Finlay L, Pedley DK. The PAWS score: validation of an early warning scoring system for the initial assessment of children in the emergency department. Emerg Med J. 2008 Nov;25(11):745-9. doi: 10.1136/emj.2007.054965.
- Results publication: PubMed 28557729Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785.
- Individual participant dataSharing planned: No
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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.
Ahmet K Özkaya, MD, phD study director
Karadeniz Technical University Faculty of Medicine
Bihter Şen Şahin, MD principal investigator
Karadeniz Technical University Faculty of Medicine
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 Critical Illness, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 6 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 May 2021. 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 Turkey (Türkiye). 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 Ahmet K Özkaya, MD, phD (+90 05554093361, kaganozkaya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified pediatric early warning score (time frame: 1 February - 31 July 2021,). The study lists 3 primary outcomes in all. 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 NCT04876872, which also lists 6 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 12 May 2021.