A Phase 1 interventional study of Milrinone and Sildenafil in Persistent Pulmonary Hypertension, sponsored by Rania Ali El-Farrash. Completed. Open to participants aged 1 Hour to 10 Days. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Rania Ali El-Farrash · Phase 1, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Rania Ali El-Farrash is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: Milrinone
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.
Drug: Sildenafil
milrinone lactate, 1mg/ml, for intra venous use only
Also known as: primacor
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
Also known as: Viagra
efficacy of milrinone versus sildenafil in treatment of PPHN
effect on oxygenation index
Time frame: 6 - 12 months
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
No study locations are listed for this record.
The record gives a start of Jan 2015, a primary completion of Apr 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Milrinone · Sildenafil
Rania Ali El-Farrash