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

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ClinicalTrials.gov Identifier: NCT00440804

Recruitment Status : Completed

First Posted : February 27, 2007

Last Update Posted : February 27, 2007

Sponsor:

Information provided by:

Farmacon

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Patent Ductus Arteriosus	Drug: ibuprofen l-lysine iv solution (NeoProfen (R) )	Phase 3

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 Design


Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	December 2002
Study Completion Date :	August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Lysine Lysine hydrochloride Ibuprofen Ibuprofen sodium Lysine acetate Ibuprofen lysine Midol

Genetic and Rare Diseases Information Center resources: Patent Ductus Arteriosus

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	28 Weeks to 34 Weeks (Child)
Sexes Eligible for Study:	All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440804

Sponsors and Collaborators

Farmacon

Investigators


Principal Investigator:	Jacob V Aranda, MD, PhD

More Information


ClinicalTrials.gov Identifier:	NCT00440804 History of Changes
Other Study ID Numbers:	FCR-00-01/CB88
First Posted:	February 27, 2007 Key Record Dates
Last Update Posted:	February 27, 2007
Last Verified:	February 2007

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 Pharmaceutical Solutions Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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