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

NCT00440804 | Completed Phase 3 DMC

• 1 other identifier: FCR-00-01/CB88
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patent Ductus Arteriosus

Keywords

patent ductus arterious

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures (Efficacy)

Secondary Outcomes (17)

• Gastrointestinal function

• Renal function

• Hematology

• Liver enzyme tests

• Serum bilirubin

Interventions

ibuprofen l-lysine iv solution (NeoProfen (R) ) DRUG

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Farmacon: lead

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jacob V Aranda, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: December 1, 2002
• Study Completion: August 1, 2005
• Last Updated: February 27, 2007

Record last verified: 2007-02