Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

NCT ID: NCT04391478

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Persistent Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

milrinone lactate, 1mg/ml, for intra venous use only

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.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Milrinone

milrinone lactate, 1mg/ml, for intra venous use only

Intervention Type DRUG

Sildenafil

50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

primacor Viagra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* gestational age \>34 weeks
* postnatal age \<10 days

Exclusion Criteria

* neonates with congenital heart disease
* neonates with congenital diaphragmatic hernia
Minimum Eligible Age

1 Hour

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rania Ali El-Farrash

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rania Ali El-Farrash

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35881893 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT 30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety of Sildenafil in Premature Infants
NCT03142568 COMPLETED PHASE2
Sildenafil and Uteroplacental Perfusion
NCT01107782 UNKNOWN PHASE2/PHASE3
PK Study of Sildenafil in Neonate
NCT02244528 COMPLETED PHASE2