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

Bronchopulmonary Dysplasia (BPD) Clinical Trial

Official title:

Efficacy and Safety of No Treatment Compared With Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants: a Randomized, Double-blind, Placebo-controlled, Non-inferiority Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128191
• Other study ID #: 2013-07-129
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: August 2019

Study information

• Verified date: January 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia (BPD)
• Ductus Arteriosus, Patent

Intervention

Drug:
• Oral ibuprofen
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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