Inhaled Nitric Oxide by Oxygen Hood in Neonates
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Respiratory Failure Infant Persistent Fetal Circulation |
Drug: inhaled Nitric Oxide Drug: Oxygen (>90% by hood) - standard therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Inhaled Nitric Oxide in Neonates With Elevated A-aDO2 Gradients Not Requiring Mechanical Ventilation |
- PaO2 one hour after the first hour of study gas [ Time Frame: one hour after the first hour of study gas ] [ Designated as safety issue: No ]
- Alveolar-arterial oxygen gradient (A-a DO2) [ Time Frame: one hour of exposure to treatment gas ] [ Designated as safety issue: No ]
- oxygen saturation by pulse oximetry (SpO2) [ Time Frame: continuously through the study ] [ Designated as safety issue: Yes ]
- need for mechanical ventilation [ Time Frame: Continuously through the study ] [ Designated as safety issue: Yes ]
- duration of oxygen therapy [ Time Frame: continuously through the study ] [ Designated as safety issue: No ]
- Methemoglobin level in post-ductal arterial blood (MetHb) [ Time Frame: Hourly until completion of study in infant ] [ Designated as safety issue: Yes ]
- Platelet count [ Time Frame: As needed if bleeding ] [ Designated as safety issue: Yes ]
- Systemic blood pressure [ Time Frame: hourly ] [ Designated as safety issue: Yes ]
- Environmental NO and NO2 exposure [ Time Frame: Hourly ] [ Designated as safety issue: Yes ]
| Enrollment: | 8 |
| Study Start Date: | March 1999 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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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).
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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:
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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.
Eligibility| Ages Eligible for Study: | up to 1 Week |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Alabama | |
| Regional Neonatal ICU, University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| 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 |
| Study First Received: | August 8, 2008 |
| Last Updated: | August 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
Hypoxia Respiratory failure Infant, term Nitric oxide |
Additional relevant MeSH terms:
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Persistent Fetal Circulation Syndrome Respiratory Insufficiency Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Infant, Newborn, Diseases Respiration Disorders Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on June 13, 2013