Feasibility Study for Neurodevelopment Follow-up Study in PICU (PICUFUN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03345628
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2017
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Davinia Withington, McGill University Health Center

Brief Summary:
There is a large and growing body of animal evidence demonstrating neuroapoptosis and neurodevelopmental abnormalities after exposure to anesthetic agents. This has prompted an FDA warning concerning use of anesthetics and sedatives in children under 3 years of age. There has been very little investigation of the neurodevelopment effects of prolonged sedation in previously healthy infants in Paediatric Intensive Care. This feasibility study will recruit previously healthy infants who required respiratory support with or without sedation at up to 6 months and assess neurodevelopmental outcomes at 6 years of age.

Condition or disease Intervention/treatment
Bronchiolitis Acute Pneumonia Drug: Sedatives

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Feasibility Study to Determine Ability to Recruit and Assess Patients for a Neurodevelopment Follow-up Study in Pediatric Intensive Care
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
infants requiring intubation and ventilation who received sedatives for at least 3 days
Drug: Sedatives
sedated group received sedative drugs to tolerated intubation and ventilation
Other Name: sedation

infants who received respiratory support by non-invasive ventilation and were not sedated

Primary Outcome Measures :
  1. Wechsler Pre-school and Primary Scale of Intelligence -IV [ Time Frame: 6 years ]
    The Wechsler Preschool and Primary Scale of Intelligence consist of 14 subtests. They are designated as one of three types: core, supplemental, or optional. The core subtests are required for the computation of the Verbal, Performance, and Full Scale IQ. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3. A score of 90-109 is Average

Secondary Outcome Measures :
  1. NEuroPSYchological Assessment (NEPSY) [ Time Frame: 6 years ]
    The six functional domains below are made up of 32 subtests and four delayed tasks. These domains are theoretically, not statistically, derived. The subtests were designed to assess cognitive abilities related to disorders that are typically diagnosed in childhood and that are required for success in an academic environment.

  2. Childhood Memory Scale (CMS™) [ Time Frame: 6 years ]
    Pearson Clinical. Assesses children's memory abilities

  3. Child Behaviour Checklist (CBCL)™ [ Time Frame: 6 years ]
    widely used checklist assessing behaviours and emotional responses

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PICU admissions for respiratory disease as specific in eligibility section recruited at 6 years of age

Inclusion Criteria:

  • infants treated fro bronchiolitis or pneumonia requiring respiratory support either intubation and IPPV needing sedation OR requiring non-invasive ventilation without sedation

Exclusion Criteria:

  • prematurity less than 28 weeks, congenital heart disease, genetic or chromosomal anomalies, neurological disease, exposure to anesthesia in utero or prior to PICU admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03345628

Canada, Quebec
McGill University Health Center
Montréal, Quebec, Canada, H3Y 3A2
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Davinia Withington, Professor, McGill University Health Center Identifier: NCT03345628     History of Changes
Other Study ID Numbers: PICU FUN 2018-3310
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Davinia Withington, McGill University Health Center:
critical care

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs