Back to resultsEfficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension (ESMPPHTN)
Primary Purpose
Persistent Pulmonary Hypertension
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Milrinone
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- gestational age >34 weeks
- postnatal age <10 days
Exclusion Criteria:
- neonates with congenital heart disease
- neonates with congenital diaphragmatic hernia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
milrinone
sildenafil
Arm Description
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 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.
Outcomes
Primary Outcome Measures
efficacy of milrinone versus sildenafil in treatment of PPHN
effect on oxygenation index
Secondary Outcome Measures
final outcome
Mortality
Bleeding
Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication
Ventilation
total duration of mechanical ventilation
Ventilatory settings
highest ventilator settings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391478
Brief Title
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
Acronym
ESMPPHTN
Official Title
Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Ali El-Farrash
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
milrinone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sildenafil
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Milrinone
Other Intervention Name(s)
primacor
Intervention Description
milrinone lactate, 1mg/ml, for intra venous use only
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
Primary Outcome Measure Information:
Title
efficacy of milrinone versus sildenafil in treatment of PPHN
Description
effect on oxygenation index
Time Frame
6 - 12 months
Secondary Outcome Measure Information:
Title
final outcome
Description
Mortality
Time Frame
6 - 12 months
Title
Bleeding
Description
Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication
Time Frame
6-12 months
Title
Ventilation
Description
total duration of mechanical ventilation
Time Frame
6-12 months
Title
Ventilatory settings
Description
highest ventilator settings
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age >34 weeks
postnatal age <10 days
Exclusion Criteria:
neonates with congenital heart disease
neonates with congenital diaphragmatic hernia
12. IPD Sharing Statement
Citations:
PubMed Identifier
35881893
Citation
Imam SS, El-Farrash RA, Taha AS, Saleh GA. Milrinone Versus Sildenafil in Treatment of Neonatal Persistent Pulmonary Hypertension: A Randomized Control Trial. J Cardiovasc Pharmacol. 2022 Nov 1;80(5):746-752. doi: 10.1097/FJC.0000000000001332.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
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