Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Prematurity; Patent Ductus Arteriosus

Treatments: Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00833365

31394

Details and patient eligibility

About

The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Full description

Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Enrollment: 15 patients

Sex: All

Ages: Under 96 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Birth weight less than 1200gm
• Less than 28 weeks gestational age
• Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion criteria

• Active Bleeding
• Currently being treated for Persistent Pulmonary Hypertension (PPHN)
• Cardiac anomalies
• Chromosomal abnormalities
• Endocrine, metabolic, renal, or hepatic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Early treatment

Active Comparator group

Description:

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen

Late treatment

Active Comparator group

Description:

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Treatment:

Drug: Ibuprofen

Drug: Ibuprofen