Inhaled Nitric Oxide by Oxygen Hood in Neonates

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure; Infant; Persistent Fetal Circulation

Treatments: Drug: inhaled Nitric Oxide; Drug: Oxygen (>90% by hood) - standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00732537

F990225003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 1 hour to 1 week old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

8 participants in 2 patient groups, including a placebo group

Inhaled Nitric Oxide

Experimental group

Description:

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).

Treatment:

Drug: inhaled Nitric Oxide

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Oxygen (>90% by hood) - standard therapy