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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Farmacon
• Treatments: Ibuprofen; Pharmaceutical Solutions

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.