MedTrace Logo

Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

NCT06562036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-26

No results posted yet for this study

Summary

Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.

Conditions

  • Persistent Pulmonary Hypertension of the Newborn

Interventions

DRUG

Sildenafil

Patients were given oral sildenafil as 2 mg per kg per day, 6-hourly with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hour by nasogastric tube.

DRUG

Milrinone

In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.

Sponsors & Collaborators

  • Muhammad Aamir Latif

    lead OTHER

Principal Investigators

  • Muhammad Awais, FCPS · Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  • Abdur Rehman, FCPS · Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Pakistan

Study Locations

More Related Trials

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 NCT06562036 on ClinicalTrials.gov