Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA

February 23, 2007 updated by: Farmacon

Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus

The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age;
  • Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO);
  • Less than 72 hours of age at the time of randomization;
  • If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria;
  • Consent form signed by parent.

Exclusion Criteria:

  • Either major congenital malformations and/or chromosomal anomalies;
  • Proven, severe congenital bacterial infection;
  • Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery;
  • Treatment with pharmacological replacement steroid therapy at anytime since birth;
  • Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution);
  • Renal failure or oliguria defined as urine flow rate < 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life);
  • Platelet count < 75,000/mm 3;
  • Clinical bleeding tendency (i.e. oozing from puncture sites);
  • Expected survival less than 48 hours in the opinion of the attending neonatologist;
  • Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department;
  • Symptomatic PDA as documented by 3 of the following 5 criteria
  • Bounding pulse
  • Hyperdynamic precordium
  • Pulmonary edema
  • Increased cardiac silhouette
  • Systolic murmur Or, in view of the neonatologist is deemed to have a hemodynamically significant ductus.
  • Exposure to NSAIDs at any time since birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary Outcome Measures (Efficacy)

Secondary Outcome Measures

Outcome Measure
Exploratory outcomes:
Gastrointestinal function
Renal function
Hematology
Liver enzyme tests
Serum bilirubin
Respiratory function
Intraventricular hemorrhage
Pulmonary hemorrhage
Pulmonary hypertension
Ibuprofen concentrations
Prostanoid concentrations
CYP2C9 Genotyping
Follow-up Outcomes
Retinopathy of Prematurity
Bronchopulmonary dysplsia
Periventricular leukomalacia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farmacon

Investigators

  • Principal Investigator: Jacob V Aranda, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 23, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCR-00-01/CB88

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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