Persistent Pulmonary Hypertension
Conditions
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.
Interventions
DRUGMilrinone
milrinone lactate, 1mg/ml, for intra venous use only
DRUGSildenafil
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
Sponsors
Rania Ali El-Farrash
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 10 Days
Healthy volunteers
No
Inclusion criteria
* gestational age \>34 weeks * postnatal age \<10 days
Exclusion criteria
* neonates with congenital heart disease * neonates with congenital diaphragmatic hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of milrinone versus sildenafil in treatment of PPHN | 6 - 12 months | effect on oxygenation index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed