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

Primary Purpose

Bronchopulmonary Dysplasia (BPD)

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral ibuprofen
Normal saline
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia (BPD) focused on measuring Patent ductus arteriosus, Ibuprofen, Bronchopulmonary dysplasia

Eligibility Criteria

5 Days - 14 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral ibuprofen

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of moderate to severe BPD
Incidence of oxygen dependency at 40 weeks PMA
Mortality rate
incidence of intraventricular hemorrhage (grade 3 or greater)
Incidence of retinopathy of prematurity (stage III or greater)
Incidence of necrotizing enterocolitis (stage 2b or greater)
Duration of PDA
Duration of intubation
Duration of nasal continuous positive airway pressure (NCPAP) treatment
Cumulative duration of oxygen use
Incidence of adverse events
Growth velocity

Full Information

First Posted
April 23, 2014
Last Updated
January 9, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02128191
Brief Title
No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia (BPD)
Keywords
Patent ductus arteriosus, Ibuprofen, Bronchopulmonary dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral ibuprofen
Arm Type
Active Comparator
Arm Description
Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
Oral ibuprofen
Other Intervention Name(s)
Brufen® syrup, Samil pharm. Co., Ltd.
Intervention Description
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
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sodium chloride, Huons. Inc.
Intervention Description
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
Primary Outcome Measure Information:
Title
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
Time Frame
36 weeks PMA
Secondary Outcome Measure Information:
Title
Incidence of moderate to severe BPD
Time Frame
36 weeks PMA
Title
Incidence of oxygen dependency at 40 weeks PMA
Time Frame
40 weeks PMA
Title
Mortality rate
Time Frame
28-days since birth and 36 weeks PMA
Title
incidence of intraventricular hemorrhage (grade 3 or greater)
Time Frame
28-days since birth
Title
Incidence of retinopathy of prematurity (stage III or greater)
Time Frame
40 weeks PMA (± 2 weeks)
Title
Incidence of necrotizing enterocolitis (stage 2b or greater)
Time Frame
40 weeks PMA (± 2 weeks)
Title
Duration of PDA
Time Frame
40 weeks PMA (± 2 weeks)
Title
Duration of intubation
Time Frame
36 weeks PMA
Title
Duration of nasal continuous positive airway pressure (NCPAP) treatment
Time Frame
40 weeks PMA (± 2 weeks)
Title
Cumulative duration of oxygen use
Time Frame
40 weeks PMA (± 2 weeks)
Title
Incidence of adverse events
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Title
Growth velocity
Time Frame
40 weeks PMA (± 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational age of 30 weeks or less or birth weight of 1250 g or less born in Samsung Medical Center confirmed to have hemodynamically significant patent ductus arteriosus (PDA) during day of life (DOL) 5 to 14 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se In Sung, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32539121
Citation
Sung SI, Lee MH, Ahn SY, Chang YS, Park WS. Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Aug 1;174(8):755-763. doi: 10.1001/jamapediatrics.2020.1447.
Results Reference
derived

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

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