Detailed descriptions of key INOMAX studies
NINOS4,11: A prospective, randomized, double-blind, placebo-controlled, multicenter study of INOMAX in term and near-term (≥34 weeks gestation and ≤14 days old) infants with HRF and an oxygenation index (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 ECMO and/or death by day 120. Mean baseline OI was 43.0 ± 17.6 and 45.1 ± 22.4 for INOMAX and controls, respectively.
CINRGI4,7: 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.
I-NO/PPHN20: 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.
Konduri 200421: Konduri et al 2004 was a prospective, randomized, double-masked, multicenter trial that planned to enroll 400 infants with respiratory failure who needed assisted ventilation. Infants were required to have an OI ≥15 and <25 and be on at least 80% oxygen. After randomization, infants were initiated with 5 ppm of iNO or a simulation. The dose could be increased to 20 ppm if the increase in PaO2 was ≤20 mmHg. Infants in both groups were transitioned to standard INOMAX if HRF progressed from moderate to severe (OI reached ≥25), which meant infants could receive the benefits of INOMAX if needed. Due to slow enrollment, the study was stopped after 302 infants were enrolled (3 were excluded).
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