Inhaled Nitric Oxide by Oxygen Hood in Neonates

NCT00732537 | Completed Phase 4

• 1 other identifier: F990225003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Infant; Persistent Fetal Circulation

Keywords

Hypoxia; Respiratory failure; Infant, term; Nitric oxide

Outcome Measures

Primary Outcomes (1)

• PaO2 one hour after the first hour of study gas

  one hour after the first hour of study gas

Secondary Outcomes (8)

• Alveolar-arterial oxygen gradient (A-a DO2)

  one hour of exposure to treatment gas

• oxygen saturation by pulse oximetry (SpO2)

  continuously through the study

• need for mechanical ventilation

  Continuously through the study

• duration of oxygen therapy

  continuously through the study

• Methemoglobin level in post-ductal arterial blood (MetHb)

  Hourly until completion of study in infant

Study Arms (2)

Inhaled Nitric Oxide

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

inhaled Nitric Oxide DRUG

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.

Also known as: iNO, Nitric Oxide

Inhaled Nitric Oxide

Oxygen (>90% by hood) - standard therapy DRUG

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.

Also known as: Oxygen, Head box

Placebo

Eligibility Criteria

• Age: 1 Hour - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants with major malformations
• Infants with cardiac disease

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Regional Neonatal ICU, University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Ambalavanan N, St John E, Carlo WA, Bulger A, Philips JB 3rd. Feasibility of nitric oxide administration by oxygen hood in neonatal pulmonary hypertension. J Perinatol. 2002 Jan;22(1):50-6. doi: 10.1038/sj.jp.7210652.

  PMID: 11840243 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Persistent Fetal Circulation Syndrome; Hypoxia

Interventions

Nitric Oxide; Oxygen; Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Hypertension, Pulmonary; Lung Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Chalcogens; Elements; Gases; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Namasivayam Ambalavanan, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: March 1, 1999
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

US (1)