NCT04876872

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
894

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 3, 2021

Last Update Submit

May 8, 2021

Conditions

Keywords

critically ill childpediatric early warning scoremPEWSmPRISA II

Outcome Measures

Primary Outcomes (3)

  • modified pediatric early warning score

    modified pediatric early warning score for each child during Severe Acute Respiratory Syndrome Causing Coronavirus Disease

    1 February - 31 July 2021,

  • mPRISA II

    mPRISA II score for each child during COVID-19 pandemic

    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.

    1 February - 31 July 2021

Secondary Outcomes (6)

  • Length of stay in pediatric emergency

    1 February - 31 July 2021

  • number of children who returned to the emergency service

    1 February - 31 July 2021

  • which service is admitted to

    1 February - 31 July 2021

  • number of children with severe acute respiratory syndrome coronavirus 2

    1 February - 31 July 2021

  • children who contacted the person with COVID-19

    1 February - 31 July 2021

  • +1 more secondary outcomes

Study Arms (1)

pediatric patients

whole pediatric patients who admitted to the pediatric emergency unit in Farabi Hospital, Trabzon, Turkey

Other: no intervention

Interventions

no intervention

pediatric patients

Eligibility Criteria

Age28 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients aged between 28 days and 18 years who applied to the Pediatric Emergency Unit

You may qualify if:

  • \- Pediatric patients aged between 28 days and 18 years, who applied to the Pediatric Emergency Unit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Medicine Farabi Hospital

Trabzon, 9061080, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

    PMID: 15687449BACKGROUND
  • Lambert 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.

  • Jagt 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.

  • Skaletzky 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.

  • Egdell 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.

  • Barak-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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmet K Özkaya, MD, phD

    Karadeniz Technical University Faculty of Medicine

    STUDY DIRECTOR
  • Bihter Şen Şahin, MD

    Karadeniz Technical University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet K Özkaya, MD, phD

CONTACT

Bihter Şen Şahin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karadeniz Technical University, Head of Department of Pediatric Emergency

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 7, 2021

Study Start

February 1, 2021

Primary Completion

July 31, 2021

Study Completion

September 15, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations