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

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

Sponsoren

Hauptsponsor: Mallinckrodt

Quelle Mallinckrodt
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Terminated
Anfangsdatum May 2002
Fertigstellungstermin June 2005
Primäres Abschlussdatum June 2005
Phase Phase 1/Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
PaO2 level at baseline, then every hour for 6 hours
Sekundäres Ergebnis
Messen Zeitfenster
Methemoglobin level at baseline then every hour of treatment
Alveolar-arterial oxygen gradient and ratio after 1 hour of treatment
Einschreibung 7
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: nitric oxide for inhalation

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

Armgruppenetikett: 1

Anderer Name: INOmax

Interventionsart: Drug

Interventionsname: Oxygen

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

Armgruppenetikett: 2

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: N/A

Maximales Alter: 120 Hours

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Waldemar Carlo, MD Principal Investigator University of Alabama at Birmingham
Ort
Einrichtung: The University of Alabama Birmingham
Standort Länder

United States

Überprüfungsdatum

October 2016

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: 1

Art: Experimental

Beschreibung: Nitric Oxide for Inhalation

Etikette: 2

Art: Placebo Comparator

Beschreibung: oxygen

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov