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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00041548
• Other study ID #: CARLW1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 10, 2002
• Last updated: October 18, 2016
• Start date: May 2002
• Est. completion date: June 2005

Study information

• Verified date: October 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis
• Anoxia
• Hypoxemia
• Lung Disease
• Lung Diseases
• Respiratory Acidosis

Intervention

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

Locations

Country	Name	City	State
United States	The University of Alabama Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2 level		at baseline, then every hour for 6 hours	No
Secondary	Methemoglobin level		at baseline then every hour of treatment	Yes
Secondary	Alveolar-arterial oxygen gradient and ratio		after 1 hour of treatment	No