NCT04391478

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

October 1, 2015

Last Update Submit

May 14, 2020

Conditions

Persistent Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • efficacy of milrinone versus sildenafil in treatment of PPHN

    effect on oxygenation index

    6 - 12 months

Secondary Outcomes (4)

  • final outcome

    6 - 12 months

  • Bleeding

    6-12 months

  • Ventilation

    6-12 months

  • Ventilatory settings

    6-12 months

Study Arms (2)

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.

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.

Drug: Sildenafil

Interventions

MilrinoneDRUG

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

Also known as: primacor
milrinone
SildenafilDRUG

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

Also known as: Viagra
sildenafil

Eligibility Criteria

Age1 Hour - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • neonates with congenital heart disease
  • neonates with congenital diaphragmatic hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35881893DERIVED

MeSH Terms

Interventions

MilrinoneSildenafil Citrate

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesSulfonesSulfur CompoundsPiperazinesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 1, 2015

First Posted

May 18, 2020

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

May 18, 2020

Record last verified: 2020-05