Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
Phase 1
Completed
- Conditions
- Persistent Pulmonary Hypertension
- Interventions
- Registration Number
- NCT04391478
- Lead Sponsor
- Rania Ali El-Farrash
- Brief Summary
Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- gestational age >34 weeks
- postnatal age <10 days
Exclusion Criteria
- neonates with congenital heart disease
- neonates with congenital diaphragmatic hernia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description milrinone 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. sildenafil 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.
- Primary Outcome Measures
Name Time Method efficacy of milrinone versus sildenafil in treatment of PPHN 6 - 12 months effect on oxygenation index
- Secondary Outcome Measures
Name Time Method final outcome 6 - 12 months Mortality
Bleeding 6-12 months Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication
Ventilation 6-12 months total duration of mechanical ventilation
Ventilatory settings 6-12 months highest ventilator settings