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

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Collaborators:
University of Pennsylvania
Bedford Pharmaceuticals
American Medical Association
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01088997
First received: March 12, 2010
Last updated: June 2, 2016
Last verified: June 2016
Results First Received: May 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Persistent Fetal Circulation Syndrome
Intervention: Drug: Milrinone Lactate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in June 2010 at three large academic medical centers. The study was closed to enrollment at all sites in November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Milrinone Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
Low Dose Milrinone Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.

Participant Flow:   Overall Study
    High Dose Milrinone     Low Dose Milrinone  
STARTED     7     5  
COMPLETED     4     2  
NOT COMPLETED     3     3  
Physician Decision                 1                 1  
Req. Extracorporeal membrane oxygenation                 1                 1  
Excluded prior to receiving drug                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Milrinone Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
Low Dose Milrinone Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
Total Total of all reporting groups

Baseline Measures
    High Dose Milrinone     Low Dose Milrinone     Total  
Number of Participants  
[units: participants]
  7     5     12  
Age  
[units: participants]
     
<=18 years     7     5     12  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     4     5  
Male     6     1     7  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     0     2  
White     2     2     4  
More than one race     1     3     4  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     7     5     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)   [ Time Frame: 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) ]

2.  Secondary:   Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion   [ Time Frame: for up to 24 hours after start of infusion ]

3.  Secondary:   Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion   [ Time Frame: Up to 24 hours after start of infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study enrollment was terminated early resulting in a small number of evaluable subjects for analysis.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Haresh Kirpalani, MD, MSc
Organization: Children's Hospital of Philadelphia
phone: 215-590-2455
e-mail: kirpalanih@email.chop.edu



Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01088997     History of Changes
Other Study ID Numbers: 09-007384
Study First Received: March 12, 2010
Results First Received: May 20, 2015
Last Updated: June 2, 2016
Health Authority: United States: Food and Drug Administration