Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

August 22, 2024 updated by: Muhammad Aamir Latif

Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 60000
        • Children's Hospital and Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of either gender
  • Aged between 1-28 days
  • Birth weight above 2000 grams
  • Diagnosed with persistent pulmonary hypertension (as per echocardiography)

Exclusion Criteria:

  • Neonates having congenital heart defects (CHDs)
  • Congenital diaphragmatic hernia
  • Lung anomalies
  • History of any surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sildenafil
Patients were given oral sildenafil at 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 hours by nasogastric tube.
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.
Experimental: Sildenafil + 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pulmonary artery systolic pressure
Time Frame: 72 hours
Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Muhammad Awais, FCPS, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
  • Study Director: Abdur Rehman, FCPS, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

August 17, 2024

First Submitted That Met QC Criteria

August 17, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAWAIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with other researchers on a reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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