Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension

• Status: Not yet recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when it is started early in these patients, therefore we plan a randomized clinical trial to determine the efficacy and safety of the administration of intravenous sildenafil for early management of newborns with persistent pulmonary hypertension of the newborn.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad del Norte
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Newborns with gestational age ≥ 34 weeks and less than 10 days old, from the delivery room, joint accommodation, surgery at the Niño Jesus Hospital and referred from other institutions with an echocardiographic diagnosis of persistent pulmonary hypertension of the newborn. A diagnosis of persistent pulmonary hypertension of the newborn will be made if any of the following criteria are identified in the absence of cyanotic congenital heart disease by echocardiography: Tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of systemic systolic blood pressure; intraventricular septum that flattens or slopes into the left ventricular cavity; bidirectional or right-to-left flow through patent ductus arteriosus; pulmonary artery acceleration time <40 milliseconds

Exclusion Criteria:

• Congenital heart disease or fatal congenital anomalies

• Oxygenation Index (IO) > 15

• No parental consent