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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Disease Hypoxemia Respiratory Acidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Nitric Oxide for Inhalation

Group Type EXPERIMENTAL

nitric oxide for inhalation

Intervention Type DRUG

given at 20 ppm for 1 hour then weaned off over 4 hours

2

oxygen

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type DRUG

given at 20 ppm for one hour, then weaned off over four hours

Interventions

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nitric oxide for inhalation

given at 20 ppm for 1 hour then weaned off over 4 hours

Intervention Type DRUG

Oxygen

given at 20 ppm for one hour, then weaned off over four hours

Intervention Type DRUG

Other Intervention Names

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INOmax

Eligibility Criteria

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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

Maximum Eligible Age

120 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No