INOMAX Detailed Study Descriptions |
INOMAX® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
INOMAX Important Safety Information (ISI)
INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
Study Descriptions
NINOS: A randomized, physician-blinded, placebo-controlled, multicenter study of INOMAX in term and near-term newborns (≥34 weeks’ gestation and ≤14 days old) with HRF and an OI≥25 who required assisted ventilation. Patients received the most aggressive forms of therapy before randomization. Patients received either INOMAX 20 ppm (n=114) or 100% oxygen (n=121) for a maximum of 14 days. The primary endpoint was use of extracorporeal membrane oxygenation and/or death by day 120. Mean baseline OI was 43 ± 17.6 and 45.1 ± 22.4 for INOMAX and controls, respectively.
CINRGI: A randomized, physician-blinded, placebo-controlled, multicenter study of low-dose INOMAX in near-term newborns (>34 weeks’ gestation and ≤4 days old) with PPHN and an OI≥25 who required assisted ventilation. INOMAX (n=126) was dosed as 20 ppm for up to 24 hours, followed by 5 ppm up to 96 hours. Patients randomized to placebo received nitrogen gas (n=122). The primary endpoint was use of extracorporeal membrane oxygenation. Mean baseline OI was 37 ± 24 and 41 ± 21 for INOMAX and controls, respectively.
INOT 01/02: A randomized, double-masked, placebo-controlled, dose-response, multicenter study of INOMAX (5, 20, or 80 ppm) for the early treatment of PPHN of the term newborn (≥37 weeks and ≥2500 g; ≥39 weeks and ≥2000 g). Patients were required to have an FiO2 of 1.0, MAP ≥10 cm H2O on a conventional ventilator, and ECG evidence of PPHN. The primary endpoint was the PPHN Major Sequelae Index—a composite of death, extracorporeal membrane oxygenation, neurologic injury, or BPD. Mean baseline OI was 24 ± 9 and 25 ± 10 for INOMAX and controls, respectively. The trial was stopped at N=155 (320 planned) due to slow recruitment.
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