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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2005

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.

Interventions

  • Drug: nitric oxide for inhalation
    • given at 20 ppm for 1 hour then weaned off over 4 hours
  • Drug: Oxygen
    • given at 20 ppm for one hour, then weaned off over four hours

Arms, Groups and Cohorts

  • Experimental: 1
    • Nitric Oxide for Inhalation
  • Placebo Comparator: 2
    • oxygen

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 120 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mallinckrodt
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Waldemar Carlo, MD, Principal Investigator, University of Alabama at Birmingham

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