Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
Overview
- Phase
- Phase 1
- Intervention
- Milrinone
- Conditions
- Persistent Pulmonary Hypertension
- Sponsor
- Rania Ali El-Farrash
- Enrollment
- 40
- Primary Endpoint
- efficacy of milrinone versus sildenafil in treatment of PPHN
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Rania Ali El-Farrash
assistant professor
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •gestational age \>34 weeks
- •postnatal age \<10 days
Exclusion Criteria
- •neonates with congenital heart disease
- •neonates with congenital diaphragmatic hernia
Arms & Interventions
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.
Intervention: Milrinone
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.
Intervention: Sildenafil
Outcomes
Primary Outcomes
efficacy of milrinone versus sildenafil in treatment of PPHN
Time Frame: 6 - 12 months
effect on oxygenation index
Secondary Outcomes
- Ventilatory settings(6-12 months)
- final outcome(6 - 12 months)
- Bleeding(6-12 months)
- Ventilation(6-12 months)