Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension (ESMPPHTN)

May 14, 2020 updated by: Rania Ali El-Farrash

Milrinone Versus Sildenafil in Treatment of PPHN in Neonates

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

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

1 hour to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gestational age >34 weeks
  • postnatal age <10 days

Exclusion Criteria:

  • neonates with congenital heart disease
  • neonates with congenital diaphragmatic hernia

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: milrinone
Milrinone is a phosphodiesterase inhibitor typ3 used in treatment of PPHN. used in dose (0.25 to 0.75 mg/kg/min) intravenous infusion compared with nasogastric sildenafil.
Drug: Milrinone
milrinone lactate, 1mg/ml, for intra venous use only
Other Names:
  • primacor
Active Comparator: sildenafil
Sildenafil is a phosphodiesterase inhibitor typ 5 used in treatment of PPHN. used in dose (0.2 to 0.5 mg/kg/6h) by nasogastric tube compared with intravenous milrinone infusion.
Drug: Sildenafil
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
Other Names:
  • Viagra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of milrinone versus sildenafil in treatment of PPHN
Time Frame: 6 - 12 months
effect on oxygenation index
6 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
final outcome
Time Frame: 6 - 12 months
Mortality
6 - 12 months
Bleeding
Time Frame: 6-12 months
Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication
6-12 months
Ventilation
Time Frame: 6-12 months
total duration of mechanical ventilation
6-12 months
Ventilatory settings
Time Frame: 6-12 months
highest ventilator settings
6-12 months

Collaborators and Investigators

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

Sponsor

Rania Ali El-Farrash

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT 30

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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