Back to resultsSafety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ibuprofen l-lysine iv solution (NeoProfen (R) )
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring patent ductus arterious
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Primary Outcome Measures (Efficacy)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00440804
Brief Title
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
Official Title
Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Farmacon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
patent ductus arterious
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibuprofen l-lysine iv solution (NeoProfen (R) )
Primary Outcome Measure Information:
Title
Primary Outcome Measures (Efficacy)
Secondary Outcome Measure Information:
Title
Gastrointestinal function
Title
Renal function
Title
Hematology
Title
Liver enzyme tests
Title
Serum bilirubin
Title
Respiratory function
Title
Intraventricular hemorrhage
Title
Pulmonary hemorrhage
Title
Pulmonary hypertension
Title
Exploratory outcomes:
Title
Ibuprofen concentrations
Title
Prostanoid concentrations
Title
CYP2C9 Genotyping
Title
Follow-up Outcomes
Title
Retinopathy of Prematurity
Title
Bronchopulmonary dysplsia
Title
Periventricular leukomalacia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
34 Weeks
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob V Aranda, MD, PhD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
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