Clinical trial NCT00732537: Inhaled Nitric Oxide by Oxygen Hood in Neonates
Official title: Inhaled Nitric Oxide in Neonates With Elevated A-aDO2 Gradients Not Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
Infant
Persistent Fetal Circulation
Keywords: Hypoxia
Respiratory failure
Infant, term
Nitric oxide
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: PaO2 one hour after the first hour of study gas
timeFrame: one hour after the first hour of study gas
Secondary outcomes:
measure: Alveolar-arterial oxygen gradient (A-a DO2)
timeFrame: one hour of exposure to treatment gas
measure: oxygen saturation by pulse oximetry (SpO2)
timeFrame: continuously through the study
measure: need for mechanical ventilation
timeFrame: Continuously through the study
measure: duration of oxygen therapy
timeFrame: continuously through the study
measure: Methemoglobin level in post-ductal arterial blood (MetHb)
timeFrame: Hourly until completion of study in infant
measure: Platelet count
timeFrame: As needed if bleeding
measure: Systemic blood pressure
timeFrame: hourly
measure: Environmental NO and NO2 exposure
timeFrame: Hourly
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regional Neonatal ICU, University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Namasivayam Ambalavanan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.