A Phase 3 interventional study of Nitric Oxide and No Intervention in Acute Respiratory Distress Syndrome, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2015-04-24.
Sponsored by Children's Hospital of Philadelphia · Phase 3, Interventional, and Treatment
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.
At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in oxygenation allows there to be decreased time on FiO2>0.60, 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.
Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first 4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for the next 4 hours)..
Blood gases were monitored once an hour during study participation (total of 8 hours). Final PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be randomized to receive Nitric Oxide (NO) immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide (NO) will be turned off and subjects will receive no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects will receive standard clinical are. Blood gases will be monitored once an hour for 4 hours.
Drug: Nitric Oxide · Other: No Intervention
Subjects will be randomized to receive no intervention (no nitric oxide) for he first 4 hours of study participation. During this time, all subjects will receive standard clinical care. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide will be turned on and subjects will receive 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours.
Drug: Nitric Oxide · Other: No Intervention
Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.
Also known as: Inhaled Nitric Oxide
Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
Mean PaO2/FiO2 Ratio
Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared
Time frame: 8 hours
Patients were recruited from the Pediatric Intensive Care Unit from 2000-2008.
| Milestone | Nitric Oxide First | Delayed Nitric Oxide |
|---|---|---|
| Started | 24 | 28 |
| Completed | 24 | 28 |
| Not completed | 0 | 0 |
Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared
| mmHg | Immediate Nitric Oxide Treatment | Delayed Nitric Oxide Treatment |
|---|---|---|
| Mean PaO2/FiO2 Ratio | 115.6 ± 40.6 | 115.9 ± 40 |
Collected over All subjects were followed for 8 hours during study participation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Treatment With Nitric Oxide | — | 0/24 (0%) | 0/24 (0%) |
| Delayed Treatment With Nitric Oxide | — | 0/28 (0%) | 0/28 (0%) |
| Age, Categorical(Participants) | Nitric Oxide First | Delayed Nitric Oxide | Total |
|---|---|---|---|
| <=18 years | 24 | 28 | 52 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Nitric Oxide First | Delayed Nitric Oxide | Total |
|---|---|---|---|
| Mean | 9.93 ± 6.79 | 8.06 ± 6.28 | 8.84 ± 6.5 |
| Sex: Female, Male(Participants) | Nitric Oxide First | Delayed Nitric Oxide | Total |
|---|---|---|---|
| Female | 10 | 14 | 24 |
| Male | 14 | 14 | 28 |
| Region of Enrollment(participants) | Nitric Oxide First | Delayed Nitric Oxide | Total |
|---|---|---|---|
| United States | 24 | 28 | 52 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome→
Children's Hospital of Philadelphia