Feasibility Study for Neurodevelopment Follow-up Study in PICU

NCT03345628 | Unknown

• 1 other identifier: PICU FUN 2018-3310
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 1 year of age and assess neurodevelopmental outcomes at 6 years of age.

Conditions

Bronchiolitis Acute; Pneumonia

Keywords

sedation; critical care; infant; neurodevelopment

Outcome Measures

Primary Outcomes (1)

• Wechsler Pre-school and Primary Scale of Intelligence -IV

  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

  6 years

Secondary Outcomes (3)

• NEuroPSYchological Assessment (NEPSY)

  6 years

• Childhood Memory Scale (CMS™)

  6 years

• Child Behaviour Checklist (CBCL)™

  6 years

Study Arms (2)

sedated

infants requiring intubation and ventilation who received sedatives for at least 3 days

Drug: Sedatives

non-sedated

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

Interventions

Sedatives DRUG

sedated group received sedative drugs to tolerated intubation and ventilation

Also known as: sedation

sedated

Eligibility Criteria

• Age: Up to 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

PICU admissions for respiratory disease as specified in eligibility section recruited at 6 years of age

You may qualify if:

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

You may not qualify if:

• prematurity less than 28 weeks, congenital heart disease, genetic or chromosomal anomalies, neurological disease, exposure to anesthesia in utero or prior to PICU admission, GA longer than 60 minutes or repeated PICU sedation since original admission.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• St. Justine's Hospital: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3Y 3A2, Canada

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)