Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Persistent pulmonary hypertension of newbornPPHNPersistent pulmonary hypertensionPulmonary hypertensionPulmonary hypertension of newborn

Outcome Measures

Primary Outcomes (1)

Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)
The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay.
End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight)

Secondary Outcomes (2)

Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion
for up to 24 hours after start of infusion
Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion
Up to 24 hours after start of infusion

Study Arms (2)

High Dose Milrinone

EXPERIMENTAL

Subjects will receive a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours.

Drug: Milrinone Lactate

Low Dose Milrinone

EXPERIMENTAL

Subjects will receive a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours.

Drug: Milrinone Lactate

Interventions

Milrinone LactateDrug

Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.

Also known as: Milrinone

High Dose MilrinoneLow Dose Milrinone

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 10 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Gestational age \> 34 weeks
Post-natal age \< 10 days

Sponsors & Collaborators

Bedford Pharmaceuticals
Industrycollaborator
American Medical Association
Othercollaborator
Thrasher Research Fund

Study Sites (2)

Children's Hospital of Michigan/Hutzel Women's Hospital

Detroit, Michigan, 48201-2196, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

MeSH Terms

Conditions

Persistent Fetal Circulation SyndromeHypertension, Pulmonary

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridines

Limitations and Caveats

Study enrollment was terminated early resulting in a small number of evaluable subjects for analysis.

Results Point of Contact

Title: Haresh Kirpalani, MD, MSc
Organization: Children's Hospital of Philadelphia

Study Officials

Haresh Kirpalani, MD
Children's Hospital of Philadelphia
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 18, 2010

Study Start

June 2010

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

High Dose Milrinone

Low Dose Milrinone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

High Dose Milrinone

Low Dose Milrinone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations