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

Patent Ductus Arteriosus Clinical Trial

Official title:

Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440804
• Other study ID #: FCR-00-01/CB88
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2007
• Last updated: February 23, 2007
• Start date: December 2002
• Est. completion date: August 2005

Study information

• Verified date: February 2007
• Source: Farmacon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Gender: Both
• Age group: 28 Weeks to 34 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• ibuprofen l-lysine iv solution (NeoProfen (R) )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Farmacon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measures (Efficacy)
Secondary	Gastrointestinal function
Secondary	Renal function
Secondary	Hematology
Secondary	Liver enzyme tests
Secondary	Serum bilirubin
Secondary	Respiratory function
Secondary	Intraventricular hemorrhage
Secondary	Pulmonary hemorrhage
Secondary	Pulmonary hypertension
Secondary	Exploratory outcomes:
Secondary	Ibuprofen concentrations
Secondary	Prostanoid concentrations
Secondary	CYP2C9 Genotyping
Secondary	Follow-up Outcomes
Secondary	Retinopathy of Prematurity
Secondary	Bronchopulmonary dysplsia
Secondary	Periventricular leukomalacia