Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

October 18, 2016 updated by: Mallinckrodt
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The University of Alabama Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nitric Oxide for Inhalation
Drug: nitric oxide for inhalation
given at 20 ppm for 1 hour then weaned off over 4 hours
Other Names:
  • INOmax
Placebo Comparator: 2
oxygen
Drug: Oxygen
given at 20 ppm for one hour, then weaned off over four hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PaO2 level
Time Frame: at baseline, then every hour for 6 hours
at baseline, then every hour for 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Methemoglobin level
Time Frame: at baseline then every hour of treatment
at baseline then every hour of treatment
Alveolar-arterial oxygen gradient and ratio
Time Frame: after 1 hour of treatment
after 1 hour of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

July 10, 2002

First Submitted That Met QC Criteria

July 10, 2002

First Posted (Estimate)

July 11, 2002

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARLW1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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