Persistent Pulmonary HypertensionPhase 1ESMPPHTNNCT04391478
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
A Phase 1 study testing Milrinone and Sildenafil in people with Persistent Pulmonary Hypertension, run by Rania Ali El-Farrash.
Trial summary
Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 1 hour to 10 days
- Conditions the study is for
- Persistent Pulmonary Hypertension
- What is being tested?
- Milrinone and Sildenafil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age >34 weeks
- postnatal age <10 days
Who cannot join
- neonates with congenital heart disease
- neonates with congenital diaphragmatic hernia
About this study
Official title: Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.
Read the 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.
- Conditions
- Persistent Pulmonary Hypertension
- Being tested
- Milrinone, Sildenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
Also called primacor
milrinone lactate, 1mg/ml, for intra venous use only
SildenafilDrug
Also called Viagra
50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| milrinone | Active comparator | 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. Receives: Drug: Milrinone |
| sildenafil | Active comparator | 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. Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of milrinone versus sildenafil in treatment of PPHN
effect on oxygenation index
Measured: 6 - 12 months
Secondary outcomes (4)
final outcome
Mortality
Measured: 6 - 12 months
Bleeding
Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication
Measured: 6-12 months
Ventilation
total duration of mechanical ventilation
Measured: 6-12 months
Ventilatory settings
highest ventilator settings
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startJan 2015
- Primary completionApr 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Ali El-Farrash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ali El-Farrash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391478
- Sponsor's protocol ID
- NCT 30
- Acronym
- ESMPPHTN
- Status last verified
- May 2020
- First submitted
- 1 Oct 2015
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35881893
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
- ClinicalTrials.gov ID
- NCT04391478
- Acronym / sponsor ID
- ESMPPHTN / NCT 30
- Conditions
- Persistent Pulmonary Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rania Ali El-FarrashUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milrinone | Active comparator | Drug: MilrinoneMilrinone 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 | Active comparator | Drug: SildenafilSildenafil 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. |
Who may qualify
- Ages
- 1 hour to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age >34 weeks
- postnatal age <10 days
Key exclusion criteria (2 listed)
- neonates with congenital heart disease
- neonates with congenital diaphragmatic hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilrinoneAlso: primacormilrinone lactate, 1mg/ml, for intra venous use only | Drug | milrinone |
| SildenafilAlso: Viagra50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube | Drug | sildenafil |
Primary outcome
efficacy of milrinone versus sildenafil in treatment of PPHN
Time frame: 6 - 12 months
effect on oxygenation index
4 secondary outcomes
final outcome
Time frame: 6 - 12 months
Bleeding
Time frame: 6-12 months
Ventilation
Time frame: 6-12 months
Ventilatory settings
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 35881893Imam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Milrinone and Sildenafil in people with Persistent Pulmonary Hypertension, run by Rania Ali El-Farrash.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of milrinone versus sildenafil in treatment of PPHN (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.