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

Phase 2

Completed

• Conditions: Bronchopulmonary Dysplasia (BPD)
• Interventions: Drug: Oral ibuprofen; Drug: Normal saline

• Registration Number: NCT02128191
• Lead Sponsor: Samsung Medical Center

Brief Summary

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)

Detailed Description

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Study Start: 2014-07
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral ibuprofen	Oral ibuprofen	Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later
Normal saline	Normal saline	Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)	36 weeks PMA

Secondary Outcome Measures

Name	Time	Method
Incidence of oxygen dependency at 40 weeks PMA	40 weeks PMA
Duration of PDA	40 weeks PMA (± 2 weeks)
Duration of intubation	36 weeks PMA
incidence of intraventricular hemorrhage (grade 3 or greater)	28-days since birth
Growth velocity	40 weeks PMA (± 2 weeks)
Duration of nasal continuous positive airway pressure (NCPAP) treatment	40 weeks PMA (± 2 weeks)
Incidence of adverse events	participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Incidence of necrotizing enterocolitis (stage 2b or greater)	40 weeks PMA (± 2 weeks)
Mortality rate	28-days since birth and 36 weeks PMA
Incidence of retinopathy of prematurity (stage III or greater)	40 weeks PMA (± 2 weeks)
Incidence of moderate to severe BPD	36 weeks PMA
Cumulative duration of oxygen use	40 weeks PMA (± 2 weeks)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of