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

Study Description

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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

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Primary Outcome Measures (Efficacy)

Secondary Outcome Measures :

1. Gastrointestinal function
2. Renal function
3. Hematology
4. Liver enzyme tests
5. Serum bilirubin
6. Respiratory function
7. Intraventricular hemorrhage
8. Pulmonary hemorrhage
9. Pulmonary hypertension
10. Exploratory outcomes:
11. Ibuprofen concentrations
12. Prostanoid concentrations
13. CYP2C9 Genotyping
14. Follow-up Outcomes
15. Retinopathy of Prematurity
16. Bronchopulmonary dysplsia
17. Periventricular leukomalacia

Eligibility Criteria

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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

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Sponsors and Collaborators

Farmacon

Investigators

Principal Investigator:	Jacob V Aranda, MD, PhD

More Information

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