Phase 3
N=52
Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00240487 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Mean PaO2/FiO2 Ratio — 115.6; 115.9 mmHg — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitric Oxide (Drug); No Intervention (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean PaO2/FiO2 Ratio |
115.6; 115.9 | >0.05 |
Summary
This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.
Eligibility Criteria
Inclusion Criteria
- Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unit with a PaO2/FiO2 ratio less than or equal to 100, FiO2 greater than or equal to 0.60, PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5.
Exclusion Criteria
- Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation
Data sourced from ClinicalTrials.gov (NCT00240487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.