No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Bronchopulmonary Dysplasia (BPD)

Treatments: Drug: Normal saline; Drug: Oral ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02128191

2013-07-129

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)

Full description

This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.

Enrollment: 142 patients

Sex: All

Ages: 5 to 14 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. gestational age of 30 weeks or less or birth weight of 1250 g or less

2. born in Samsung Medical Center

3. confirmed to have hemodynamically significant patent ductus arteriosus (PDA) during day of life (DOL) 5 to 14

4. Definition of hemodynamically significant PDA: ductal size ≥ 1.5 mm with left-to-right shunt (or bidirectional shunt with dominant left-to-right blood flow) on the initial echocardiography plus at least one of clinical criteria.

   • Clinical criteria

     • Respiratory signs, including tachypnea, chest retraction, increased respiratory support, unable to wean respiratory support
     • Physical signs, including a murmur, hyperdynamic precordium or bounding pulses
     • Blood pressure problems, including decreased mean or diastolic pressure or increased pulse pressure
     • Signs of congestive heart failure, including cardiomegaly, hepatomegaly or pulmonary congestion

Exclusion criteria

• Mortality within the first 48 hours of life
• Ductal size < 1.5 mm on the initial echocardiography
• Right-to-left shunt or bidirectional shunting with dominant right-to-left shunt through PDA
• congenital anomaly
• bilateral intraventricular hemorrhage of grade 4
• contraindication of ibuprofen (bleeding diasthesis, platelet count 10,000/mm3 or less, serum creatinine 2.0 mg/dL or greater, necrotizing enterocolitis stage 2 or greater

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 2 patient groups, including a placebo group

Oral ibuprofen

Active Comparator group

Description:

Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later

Treatment:

Drug: Oral ibuprofen

Normal saline

Placebo Comparator group

Description:

Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm

Treatment:

Drug: Normal saline