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NCT03709199 · ClinicalTrials.gov registry record
Long Term Follow up of Children Enrolled in the REDvent Study
A clinical trial of Quality of Life and Respiratory Distress Syndrome, Adult, sponsored by Children's Hospital Los Angeles.
- Active
- Registry status
- 176
- Enrollment target
- 1
- Study location
NCT03709199 is a study of Quality of Life and Respiratory Distress Syndrome, Adult that is active but no longer recruiting, run by Children's Hospital Los Angeles. The registered enrollment target is 176 participants, below the 451-participant average among 107 other Quality of Life trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03709199, a study of Quality of Life and Respiratory Distress Syndrome, Adult, is active but no longer recruiting, sponsored by Children's Hospital Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- 176 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent). Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Health Related Quality of Life (HRQL) which may persist for years.Data in pediatric ARDS (PARDS) survivors is limited. More importantly, there are no data identifying potentially modifiable factors during ICU care which are associated with long term impairments, which may include medication choices, or complications from mechanical ventilator (MV) management in the ICU including ventilator induced lung injury (VILI) or ventilator induced diaphragm dysfunction (VIDD). The Real-time effort driven ventilator (REDvent) trial is testing a ventialtor management algorithm which may prevent VIDD and VILI. VIDD and VILI have strong biologic plausibility to affect the post-ICU health of children with likely sustained effects on lung repair and muscle strength. Moreover, common medication choices (i.e. neuromuscular blockade, corticosteroids) or other complications in the ICU (i.e. delirium) are likely to have independent effects on the long term health of these children. This proposed study will obtain serial follow-up of subjects enrolled in REDvent (intervention and control patients). The central hypothesis is that preventing VIDD, VILI and shortening time on MV will have a measureable impact on longer term function by mitigating abnormalities in pulmonary function (PFTs), neurocognitive function and emotional health, functional status and HRQL after hospital discharge for children with PARDS. For all domains, the investigators will determine the frequency, severity and trajectory of recovery of abnormalities amongst PARDS survivors after ICU discharge, identify risk factors for their development, and determine if they are prevented by REDvent. They will leverage the detailed and
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Spirometry
- DIAGNOSTIC_TEST Ventilation Inhomogeneity
- DIAGNOSTIC_TEST Diaphragm Ultrasound
- DIAGNOSTIC_TEST Respiratory Inductance Plethysmography
- DIAGNOSTIC_TEST Functional Residual Capacity
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2026-05-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03709199
The ClinicalTrials.gov registry entry for NCT03709199 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 451-participant average among 107 other Quality of Life trials with a reported enrollment target (61% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Quality of Life appearing as the primary indexed condition, and to 5 interventions - of which Spirometry is the first listed.
NCT03709199 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03709199 about?
NCT03709199 is a clinical study titled "Long Term Follow up of Children Enrolled in the REDvent Study". This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent). Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Hea...
What is the current status of trial NCT03709199?
This trial is currently active not recruiting. The enrollment target is 176 participants. The study started on 2018-10-01. Estimated completion is 2026-05-01.
What conditions does trial NCT03709199 study?
This clinical trial studies the following conditions: Quality of Life, Respiratory Distress Syndrome, Adult, Neurocognitive Dysfunction, Ventilator-Induced Lung Injury, Respiration Disorders.
What interventions are being tested in trial NCT03709199?
The interventions under investigation include: Spirometry (DIAGNOSTIC_TEST), Ventilation Inhomogeneity (DIAGNOSTIC_TEST), Diaphragm Ultrasound (DIAGNOSTIC_TEST), Respiratory Inductance Plethysmography (DIAGNOSTIC_TEST), Functional Residual Capacity (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03709199?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03709199 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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