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Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension

NCT04912726 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Sildenafil Injectable Product

The intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h).

Sponsors & Collaborators

  • Universidad del Norte

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-15
Completion
2026-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912726 on ClinicalTrials.gov