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NCT03896763 · ClinicalTrials.gov registry record · NA
PROSpect: Prone and Oscillation Pediatric Clinical Trial
A NA study of Acute Respiratory Distress Syndrome in Children, sponsored by University of Pennsylvania.
- Active
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT03896763: Active NA study of Acute Respiratory Distress Syndrome in Children, sponsored by University of Pennsylvania.
NCT03896763 is a NA study of Acute Respiratory Distress Syndrome in Children that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 600 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03896763, a NA study of Acute Respiratory Distress Syndrome in Children, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).
Primary Outcome
Our primary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more ventilator-free days. We hypothesize that a superior treatment would improve VFD by at least 2 days, a clinically meaningful difference. VFD is the number of days within 28 days that a patient is alive and free of mechanical ventilation. Improvement in VFD will be considered within the context of patient safety; specifically, patients must also exhibit a similar
Conditions Studied
Interventions
- OTHER Either supine or prone positioning and either CMV or HFOV
Study Locations (20)
California
- Children's Hospital Orange County - Orange
- Stanford Children's Health - Palo Alto
Pennsylvania
- Penn State Children's Hospital - Hershey
- Children's Hospital of Philadelphia - Philadelphia
Alabama
- Children's of Alabama - Birmingham
Arizona
- Banner Health - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Illinois
- Ann & Robert Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children at IU Health - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What the registry record for NCT03896763 still lists
NCT03896763 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Acute Respiratory Distress Syndrome in Children appearing as the primary indexed condition, and to 1 intervention - of which Either supine or prone positioning and either CMV or HFOV is the first listed.
NCT03896763 names 20 study sites across 18 states, led by California, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT03896763 about?
NCT03896763 is a clinical study titled "PROSpect: Prone and Oscillation Pediatric Clinical Trial". Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best pos...
What is the current status of trial NCT03896763?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2019-05-01. Estimated completion is 2027-01-31.
What conditions does trial NCT03896763 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome in Children.
What interventions are being tested in trial NCT03896763?
The interventions under investigation include: Either supine or prone positioning and either CMV or HFOV (OTHER).
Who is sponsoring clinical trial NCT03896763?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03896763 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03896763's enrollment target sits among peer trials
600 162nd of 2000 higher than 1,827 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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