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

This study has been completed.
Sponsor:
Information provided by:
Farmacon
ClinicalTrials.gov Identifier:
NCT00440804
First received: February 23, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Patent Ductus Arteriosus
Drug: ibuprofen l-lysine iv solution (NeoProfen (R) )
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus

Resource links provided by NLM:


Further study details as provided by Farmacon:

Primary Outcome Measures:
  • Primary Outcome Measures (Efficacy)

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

Study Start Date: December 2002
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440804

Sponsors and Collaborators
Farmacon
Investigators
Principal Investigator: Jacob V Aranda, MD, PhD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00440804     History of Changes
Other Study ID Numbers: FCR-00-01/CB88
Study First Received: February 23, 2007
Last Updated: February 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Farmacon:
patent ductus arterious

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014