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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-08-31

Brief Summary

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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)

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Detailed Description

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

Conditions

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Bronchopulmonary Dysplasia (BPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral ibuprofen

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

Group Type ACTIVE_COMPARATOR

Oral ibuprofen

Intervention Type DRUG

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

Normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Oral ibuprofen

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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Brufen® syrup, Samil pharm. Co., Ltd. Sodium chloride, Huons. Inc.

Eligibility Criteria

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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

Minimum Eligible Age

5 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No