Outcomes of Children After Hospitalization in Intensive Care Unit

NCT06124092 | Not Yet Recruiting

• 1 other identifier: CHUSJ MP-21-2023-5097
• Study Type: observational
• Target: 690
• Locations: 1 country
• Sites: 8

Brief Summary

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p). It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

Conditions

Renal Disease; Liver Diseases; Heart Diseases; Trauma Injury; Sepsis; Septic Shock; Pneumonia; Bronchiolitis

Keywords

Pediatric Intensive Care Unit; PICU

Outcome Measures

Primary Outcomes (2)

• Identify risk factors of PICS-p at 2 months post-PICU

  Identification of modifiable and non-modifiable risk factors

  2 months after PICU discharge

• Develop and validate a model predictive of PICS-p 2 months post PICU

  The model will allow detection at PICU discharge of children in need of post-PICU follow-up

  2 months after PICU discharge

Secondary Outcomes (2)

• Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU

  At 2 months, 12, 18 months and 36 months post PICU discharge

• Uncover additional post-PICU morbidities not detected within the framework of PICS-p.

  Until 36 months post PICU discharge

Other Outcomes (1)

• Describe families' healthcare requirements throughout their recovery process after PICU.

  Until 36 months post PICU discharge

Interventions

neurocognitive tests OTHER

Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.

Also known as: Quality of life

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age \<37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.

You may qualify if:

• Children ≤18yo hospitalized in PICU for ≥96 hours

You may not qualify if:

• gestational age \<37 weeks or age \>18 years at PICU entry;
• admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
• anticipated life expectancy \<1year (e.g., active do not resuscitate status).

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (8)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

BC Children Hospital

Vancouver, British Colombia, V6H 3N1, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Montreal Children Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1J 3H5, Canada

Location

MeSH Terms

Conditions

Kidney Diseases; Liver Diseases; Heart Diseases; Accidental Injuries; Sepsis; Shock, Septic; Pneumonia; Bronchiolitis

Interventions

Mental Status and Dementia Tests; Quality of Life

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Cardiovascular Diseases; Wounds and Injuries; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Geneviève Du Pont-Thibodeau, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Laurence Cucharme-Crevier, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geneviève Du Pont-Tibodeau, MD

CONTACT

514-345-4931; genevieve.du.pont-thibodeau.med@ssss.gouv.qc.ca

Laurence Ducharme-Crevier, MD

CONTACT

514-345-4931; laurence.ducharme.crevier.med@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CA (8)