NCT00240487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

8 years

First QC Date

October 14, 2005

Results QC Date

January 10, 2013

Last Update Submit

April 23, 2015

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress SyndromeARDSNitric Oxide

Outcome Measures

Primary Outcomes (1)

  • 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

    8 hours

Study Arms (2)

Nitric oxide first

ACTIVE COMPARATOR

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 OxideOther: No Intervention

Delayed nitric oxide

ACTIVE COMPARATOR

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 OxideOther: No Intervention

Interventions

Nitric OxideDRUG

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
Delayed nitric oxideNitric oxide first
No InterventionOTHER

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.

Delayed nitric oxideNitric oxide first

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Limitations and Caveats

There may be some confounding of effects of lung recruitment from high mean airway pressures over the duration of the observation period.

Results Point of Contact

Title
Richard Lin
Organization
The Children's Hospital of Philadelphia
linr@email.chop.edu
2155905505

Study Officials

  • Rodolfo I Godinez, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

September 1, 2000

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 24, 2015

Results First Posted

April 24, 2015

Record last verified: 2015-04

Locations

US(1)