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Completed

NCT Number: NCT03308513

Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illness in Turkey

It is predicted that the number of Pediatric Chronic Critical Illness increases similar to adult all over the world. The prevalence of Pediatric Chronic Critical Illness in Turkey is unknown. The investigators aimed to evaluate the etiology, comorbid conditions, demographic data, prevalence, mortality and costs of these patient in intensive care units in Turkey. In this multi-centered study, The investigators will retrospectively review the last 3 year of patients receiving treatment at the Intensive Care Unit.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yuzuncu Yil University, School of Medicine

Van, Tusba / Zeve Kampus, 65080, Turkey (Türkiye)

About this study

Patients receiving acute critical cause of ICU in the Intensive Care Unit (ICU) may be hospitalized for longer periods of time due to accompanying diseases or iatrogenic causes. This disease is called "Chronic Critical Illness" (CCI). CCI is associated with prolonged acute mechanical ventilation, but there is no definition in the literature for newborns. Pediatric CCI is estimated to be similar to adults. In the United States, the number of CCI is around 250,000, which is estimated to have doubled in the last 10 years. 50% of patients die in one year and much less than 12% recover. The estimated annual cost for the CCI in the United States is over $ 20 billion. The prevalence of Pediatric CCI in Turkey is unknown. In this study, it was aimed to investigate risk factors, mortality and cost of children with chronic critically ill and newborn patients in intensive care units in Turkey.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Critical IIlness
  • The patients who are younger than 18 years old and staying in ICU for at least 14 days.

(The patients who is newborn and stay in the intensive care unit for 30 days in addition to prematurity).

At least one of the additional criteria;

  • Prolonged acute mechanical ventilation
  • Tracheostomy
  • Sepsis
  • Severe wound (burn) or trauma
  • Encephalopathy (Post resuscitation syndrome, Asphyxia, Intra-cranial hemorrhage, Metabolic disease, etc.)
  • Traumatic brain injury
  • Status epilepticus
  • Post operative (Cardiac and noncardiac)
  • Neuromuscular disease (Spinal Muscular Dystrophy, Cerebral Palsy, Muscular Dystrophy)

Exclusion criteria

  • Patients with a disease other than a chronic critical disease
  • Patients older than 18 years

Treatment and study plan

Primary outcomes

  1. Critical care unit mortality

    Time frame: 30 Day, 90 Day, 180 Day, 365 day

    The mortality change rates in the 30th Day, 90th Day, 180th Day, 365th Day

Secondary outcomes

  1. Critical care unit costs for infant patients

    Time frame: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)

    Cost of patients staying in intensive care unit

  2. Critical care unit costs for premature newborn

    Time frame: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)

    Cost of patients staying in intensive care unit

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Collaborators

  • Izmir Ataturk Training and Research Hospital
  • Kahramanmaras Sutcu Imam University

Registry information

Official study title

Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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