Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Persistent Pulmonary Hypertension of NewbornThe aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.
Milrinone in Congenital Diaphragmatic Hernia
Congenital Diaphragmatic HerniaPersistent Pulmonary Hypertension of the Newborn2 moreInfants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.
Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory...
Persistent Pulmonary Hypertension of the NewbornHypoxemic Respiratory FailureThe purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.
The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension...
Persistent Pulmonary Hypertension of the NewbornEchocardiography1 moreThis aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.
PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn...
Persistent Pulmonary Hypertension of the NewbornThe purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs).
Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn...
Persistent Fetal Circulation SyndromeThe purpose of this pilot study is to determine a safe dose of milrinone to use in a larger study of babies with persistent pulmonary hypertension of the newborn (PPHN).
Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
InfantNewborn8 moreThis prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at >34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary...
PPHNPersistent Pulmonary Hypertension of the Newborn1 moreSildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
InfantNewborn8 moreRespiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.
Persistent Pulmonary Hypertension of the Newborn
Persistent Pulmonary Hypertension of the NewbornThe AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.