Long Term Follow up of Children Enrolled in the REDvent Study

Active, not recruitingOBSERVATIONAL
Enrollment

176

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2026

Conditions
Respiratory Distress Syndrome, AdultVentilator-Induced Lung InjuryNeurocognitive DysfunctionQuality of LifeRespiration Disorders
Interventions
DIAGNOSTIC_TEST

Ventilation Inhomogeneity

Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth.

DIAGNOSTIC_TEST

Diaphragm Ultrasound

Diaphragm thickness and contractile activity measured during tidal breathing.

DIAGNOSTIC_TEST

Respiratory Inductance Plethysmography

Measure of thoraco-abdominal asynchrony during tidal breathing

DIAGNOSTIC_TEST

Spirometry

Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques

DIAGNOSTIC_TEST

Functional Residual Capacity

Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques

DIAGNOSTIC_TEST

MIP/MEP

Measurement of maximal inspiratory and expiratory pressures during airway occlusion

DIAGNOSTIC_TEST

6 minute walk test

Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.

DIAGNOSTIC_TEST

Neurocognitive Testing

Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years).

DIAGNOSTIC_TEST

Emotional Health Assessment

In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years and the UCLA PTSD Reaction Index (UCLA RI) for children ≥ 8 years.

DIAGNOSTIC_TEST

Health Related Quality of Life

Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires.

DIAGNOSTIC_TEST

Functional Status

Survey of overall functional status, administrated by asking a series of questions to patient and families.

DIAGNOSTIC_TEST

Respiratory Status Questionnaire

Survey of respiratory health, administrated by asking a series of questions to patient and families.

Trial Locations (1)

90027

Children's Hospital Los Angeles, Los Angeles

All Listed Sponsors
lead

Children's Hospital Los Angeles

OTHER

NCT03709199 - Long Term Follow up of Children Enrolled in the REDvent Study | Biotech Hunter | Biotech Hunter