Abstract
BackgroundWe have shown earlier that inhaled nitric oxide (iNO) administered by oxygen hood reduces pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective in this study was to determine feasibility of iNO by oxygen hood in neonates with elevated alveolar-arterial oxygen gradients (A-aDO2).Methods/Principal FindingsMasked randomized controlled pilot trial. Inclusion criteria were: gestation≥34 weeks, age<7 days, with post-ductal arterial line, and A-aDO2 400–600. Infants were randomized to study gas (iNO 20 ppm or equivalent O2 flow) for 1 hr which was then weaned over the next 4 hours. Primary outcome was PaO2 one hour post-randomization. Four infants each were randomized to iNO or O2 (controls). Two of the four infants given iNO had an increase in PaO2 of >100 torr, 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 (<1 ppm) at >0.3 m from the hood.ConclusionsAdministration 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.Trial RegistrationClinicalTrials.gov NCT00041548
Highlights
Severe neonatal pulmonary hypertension affects approximately 1 in 500 term neonates [1]
Large clinical trials have shown that inhaled nitric oxide improves oxygenation in approximately 50% of infants who receive nitric oxide [2]
Two of the four infants given inhaled nitric oxide (iNO) had an increase in PaO2 of .100 torr, while oxygenation was essentially unchanged in the controls, one patient had a small increase (+22 torr) (Figure 3, Table 1)
Summary
Severe neonatal pulmonary hypertension affects approximately 1 in 500 term neonates [1]. The use of iNO administered by oxygen hood has not been systematically evaluated. It is possible that earlier administration of iNO to neonates with abnormal gas exchange, rather than later as a rescue therapy, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation and its associated morbidity. This study was designed as a pilot trial to evaluate the feasibility of NO administered by hood in neonates with elevated alveolararterial oxygen gradients (A-a DO2). Subsequent larger trials could determine if this method of NO administration can decrease the need for mechanical ventilation, ECMO, or other adverse outcomes
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