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

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.