MALLINCKRODT
INOmax has been on the market in the
The primary outcome measure of the registry was the number of PT neonates and TNT neonates with a significant response to INOmax, which was defined as at least a 25 percent improvement (decrease) from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOmax treatment. A total of 50 (90.9 percent) PT and 75 (88.2 percent) TNT neonates achieved a ?25 percent decrease in OI/SOI during treatment with INOmax. Efficacy in the PT group demonstrated non-inferiority (95 percent confidence interval: 0.0267 [-0.0333, 0.0868], with a pre-defined margin of -0.1452). In addition, the proportion of neonates with ?25 percent decrease in OI/SOI was similar across severity groups with no significant difference in time to improvement between groups.1
'These registry findings help expand our understanding of a potential role of inhaled nitric oxide therapy in preterm infants with hypoxic respiratory failure with pulmonary hypertension,' said study author
Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life.2,3 The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population.
Overall, 21 adverse events of special interest were reported in 17 patients, all of which were classified as serious events, and no serious adverse events were attributed to the study drug.
'After ending this registry much earlier than anticipated last year based on positive findings, Mallinckrodt is extremely pleased to be able to share these important data with the healthcare community and add to the body of research and real-world data for this vulnerable patient population,' said
About the Observational Registry
The Registry Evaluating Premature and Term and Near-Term Neonates with Pulmonary Hypertension Receiving Inhaled Nitric Oxide (PaTTerN) was a multicenter, prospectively defined, observational registry study that evaluated the use of INOmax to treat pulmonary PH in premature neonates (27 to less than 34 weeks gestational age) and term and near-term neonates (34 to 40 weeks gestational age).
In the 11-day study period, a total of 140 neonates (PT, n=55; TNT, n=85) were enrolled across 30 sites in
The primary outcome measure compared the incidence of subjects with at least a 25 percent improvement (decrease) from baseline in OI or SOI during the INOmax treatment period in pre-term versus term and near-term neonates with PH.
Secondary efficacy endpoints included:
The incidence of subjects with at least a 25 percent improvement in OI/SOI in each severity group of mild, moderate and severe
The time to response to INOmax up to 96 hours for each severity and age group
Evaluation of 25 percent improvement in OI/SOI with univariate and multivariate logistic regressions for baseline factors: age and severity group, disease subtype, weight, race, gender
The incidence of partial responders (
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