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Inhaled Nitric Oxide by Oxygen Hood in Neonates

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ClinicalTrials.gov Identifier: NCT00732537
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.

Condition or disease Intervention/treatment Phase
Respiratory Failure Infant Persistent Fetal Circulation Drug: inhaled Nitric Oxide Drug: Oxygen (>90% by hood) - standard therapy Phase 4

Detailed Description:
Inhaled nitric oxide (iNO) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. We have shown that iNO administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group B streptococcus-induced pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective was to determine the feasibility of iNO administration by oxygen hood in neonates with respiratory failure. Methods: A masked randomized controlled trial was performed on eight infants with respiratory failure. Inclusion criteria were: gestation>34 weeks, age<7 days, with post-ductal arterial line, and A-aDO2 400-600 on two consecutive blood gases. Infants were randomized to study gas (iNO at 20 ppm or equivalent flow of O2) for 1 hr which was then weaned over the next 4 hours. The iNO was introduced into an oxygen hood using an INOvent (INO Therapeutics, Inc). The primary outcome was the PaO2 one hour after randomization. Environmental leakage of NO and NO2 were measured. Results: Four infants were randomized to iNO and four to O2 (controls). Two of the four infants given iNO had an increase in PaO2 of >100 mm Hg, while oxygenation was unchanged in the controls. Methemoglobinemia and other adverse effects were not noted in any infant. Environmental levels of NO and NO2 were minimal (<1ppm) to undetectable at >0.3m from the hood. Conclusions: Administration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Nitric Oxide in Neonates With Elevated A-aDO2 Gradients Not Requiring Mechanical Ventilation
Study Start Date : March 1999
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Inhaled Nitric Oxide
iNO started at 20 ppm for 1 hour. The gas was then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off).
Drug: inhaled Nitric Oxide
iNO started at 20 ppm for 1 hour, then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). If >5% drop in oxygen saturation was observed during weaning, study gas was increased to the previous concentration and weaning done 2 hourly. If > 5% drop in oxygen saturation or >5% Methemoglobin was observed during initial administration, the study gas would be weaned over 30 minutes and the infant would exit. The iNO was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. Monitoring of O2, NO2, NO was done by placing the end of the sample line inside the oxyhood. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
Other Names:
  • iNO
  • Nitric Oxide
Placebo Comparator: Placebo
The Oxygen at high concentration (>90%), which was standard therapy for PPHN, was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda).
Drug: Oxygen (>90% by hood) - standard therapy
Oxygen (>90% by hood, standard therapy for PPHN prior to intubation) was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. If the baby was randomized to the control group and did not receive NO, the INOmax® cylinder was opened and used only to pressurize the system, which prevented the "Low NO Pressure" alarm. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
Other Names:
  • Oxygen
  • Head box


Outcome Measures

Primary Outcome Measures :
  1. PaO2 one hour after the first hour of study gas [ Time Frame: one hour after the first hour of study gas ]

Secondary Outcome Measures :
  1. Alveolar-arterial oxygen gradient (A-a DO2) [ Time Frame: one hour of exposure to treatment gas ]
  2. oxygen saturation by pulse oximetry (SpO2) [ Time Frame: continuously through the study ]
  3. need for mechanical ventilation [ Time Frame: Continuously through the study ]
  4. duration of oxygen therapy [ Time Frame: continuously through the study ]
  5. Methemoglobin level in post-ductal arterial blood (MetHb) [ Time Frame: Hourly until completion of study in infant ]
  6. Platelet count [ Time Frame: As needed if bleeding ]
  7. Systemic blood pressure [ Time Frame: hourly ]
  8. Environmental NO and NO2 exposure [ Time Frame: Hourly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestation >34 weeks at birth
  • age <7 days
  • post-ductal arterial line
  • an A-aDO2 of 400 to 600 on two blood gases, at least 30 minutes apart.

Exclusion Criteria:

  • Infants with major malformations
  • Infants with cardiac disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732537


Locations
United States, Alabama
Regional Neonatal ICU, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Namasivayam Ambalavanan, MD University of Alabama at Birmingham
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
More Information

Publications:
Responsible Party: Namasivayam Ambalavanan MD and Waldemar A. Carlo MD, Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00732537     History of Changes
Other Study ID Numbers: F990225003
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by University of Alabama at Birmingham:
Hypoxia
Respiratory failure
Infant, term
Nitric oxide

Additional relevant MeSH terms:
Nitric Oxide
Respiratory Insufficiency
Persistent Fetal Circulation Syndrome
Respiration Disorders
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Infant, Newborn, Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents