Back to resultsInhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Primary Purpose
Lung Disease, Hypoxemia, Respiratory Acidosis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nitric oxide for inhalation
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease
Eligibility Criteria
Inclusion criteria: Gestational age >34 completed weeks (>=35) Age <48 hours A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood Post-ductal arterial access Admitted to The University of Alabama Birmingham Regional NICU Exclusion criteria: Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO) Rapid deterioration requiring mechanical ventilation before entry into the study Major malformations Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia
Sites / Locations
- The University of Alabama Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Nitric Oxide for Inhalation
oxygen
Outcomes
Primary Outcome Measures
PaO2 level
Secondary Outcome Measures
Methemoglobin level
Alveolar-arterial oxygen gradient and ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00041548
Brief Title
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Official Title
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
Detailed Description
It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.
This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Hypoxemia, Respiratory Acidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nitric Oxide for Inhalation
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
oxygen
Intervention Type
Drug
Intervention Name(s)
nitric oxide for inhalation
Other Intervention Name(s)
INOmax
Intervention Description
given at 20 ppm for 1 hour then weaned off over 4 hours
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
given at 20 ppm for one hour, then weaned off over four hours
Primary Outcome Measure Information:
Title
PaO2 level
Time Frame
at baseline, then every hour for 6 hours
Secondary Outcome Measure Information:
Title
Methemoglobin level
Time Frame
at baseline then every hour of treatment
Title
Alveolar-arterial oxygen gradient and ratio
Time Frame
after 1 hour of treatment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Gestational age >34 completed weeks (>=35)
Age <48 hours
A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
Post-ductal arterial access
Admitted to The University of Alabama Birmingham Regional NICU
Exclusion criteria:
Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
Rapid deterioration requiring mechanical ventilation before entry into the study
Major malformations
Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19183804
Citation
Ambalavanan N, El-Ferzli GT, Roane C, Johnson R, Carlo WA. Nitric oxide administration using an oxygen hood: a pilot trial. PLoS One. 2009;4(2):e4312. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.
Results Reference
derived
Learn more about this trial
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
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