Phase 4 Registry Evaluating Inomax Gas in Premature Babies with PH Enrolls First Participant
The Phase 4 multicenter, observational PaTTerN registry evaluating the use of Inomax (nitric oxide) in newborns with pulmonary hypertension (PH) has enrolled its first patient, Mallinckrodt Pharmaceuticals announced.
The registry (NCT03132428) is actively recruiting participants, said the British drug conglomerate.
Persistent PH in newborns is a serious, sometimes fatal, condition marked by increased pulmonary vascular pressure. Researchers in this study will evaluate the efficacy of Inomax gas when inhaled by premature neonates —babies with a gestational age of 27 to 34 weeks — versus term and near-term neonates, or those with a gestational age of 34 to 40 weeks.
The study is expected to include 168 babies. All will be evaluated for their response to Inomax during the 96-hour treatment period and another seven days to assess the treatment’s safety. Patients may be discharged before the 11-day total follow-up period if their doctors see fit.
The study’s primary goal is to assess and compare the number of participants who show at least a 25 percent improvement in oxygenation index (for those who are not on ventilation), compared to baseline. The trial should end by 2022.
The U.S. Food and Drug Administration (FDA) approved Inomax for term and near-term neonates with PH and PH-associated hypoxic respiratory failure — a condition where oxygen in the blood is at abnormally low concentrations — needing ventilator support. Inomax is designed to improve oxygenation and reduce the need for external sources of oxygen.
“We are pleased to enroll the first patient in this multicenter, observational registry, which will generate data and insights concerning inhaled nitric oxide use in preterm neonates with pulmonary hypertension compared with term and near-term neonates with pulmonary hypertension,” Dr. Steven Romano, executive vice-president and chief scientific officer at Mallinckrodt, said in a press release.