Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00440804 |
Recruitment Status
:
Completed
First Posted
: February 27, 2007
Last Update Posted
: February 27, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patent Ductus Arteriosus | Drug: ibuprofen l-lysine iv solution (NeoProfen (R) ) | Phase 3 |
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 |

- Primary Outcome Measures (Efficacy)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 28 Weeks to 34 Weeks (Child) |
Sexes Eligible for Study: | All |
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.

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
Principal Investigator: | Jacob V Aranda, MD, PhD |
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 |