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

Rania Ali El-Farrash40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Persistent Pulmonary Hypertension

Interventions

MilrinoneDRUG

milrinone lactate, 1mg/ml, for intra venous use only

SildenafilDRUG

50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube

Eligibility

Sex: ALLMin age: 1 HourMax age: 10 Days

Medical Language ↔ Plain English

Inclusion Criteria: * gestational age \>34 weeks * postnatal age \<10 days Exclusion Criteria: * neonates with congenital heart disease * neonates with congenital diaphragmatic hernia

Outcomes

Primary Outcomes

efficacy of milrinone versus sildenafil in treatment of PPHN

effect on oxygenation index

Time frame: 6 - 12 months

Secondary Outcomes

final outcome

Mortality

Time frame: 6 - 12 months

Bleeding

Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication

Time frame: 6-12 months

Ventilation

total duration of mechanical ventilation

Time frame: 6-12 months

Ventilatory settings

highest ventilator settings

Time frame: 6-12 months

Data from ClinicalTrials.gov

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