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

Persistent Pulmonary Hypertension Clinical Trial

— ESMPPHTN  

Official title:

Milrinone Versus Sildenafil in Treatment of PPHN in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391478
• Other study ID #: NCT 30
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

Inclusion Criteria:

• gestational age >34 weeks

• postnatal age <10 days

Exclusion Criteria:

• neonates with congenital heart disease

• neonates with congenital diaphragmatic hernia

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Pulmonary Hypertension

Intervention

Drug:
• Milrinone
milrinone lactate, 1mg/ml, for intra venous use only
• Sildenafil
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rania Ali El-Farrash

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of milrinone versus sildenafil in treatment of PPHN	effect on oxygenation index	6 - 12 months
Secondary	final outcome	Mortality	6 - 12 months
Secondary	Bleeding	Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication	6-12 months
Secondary	Ventilation	total duration of mechanical ventilation	6-12 months
Secondary	Ventilatory settings	highest ventilator settings	6-12 months