Bronchopulmonary Dysplasia (BPD)Phase 2NCT02128191
No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants
A Phase 2 study testing Oral ibuprofen and Normal saline in people with Bronchopulmonary Dysplasia (BPD), run by Samsung Medical Center at 1 site in South Korea.
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) Read more about this study
- Who is it for?
- Ages 5 to 14 days
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Oral ibuprofen and Normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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)
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Being tested
- Oral ibuprofen, Normal saline
- Keywords
- Patent ductus arteriosus, Ibuprofen, Bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ibuprofenDrug
Also called Brufen® syrup, Samil pharm. Co., Ltd.
Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later
Normal salineDrug
Also called Sodium chloride, Huons. Inc.
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
| Study group | Role | What they receive |
|---|---|---|
| Oral ibuprofen | Active comparator | Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later Receives: Drug: Oral ibuprofen |
| Normal saline | Placebo comparator | Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
Measured: 36 weeks PMA
Secondary outcomes (12)
Incidence of moderate to severe BPD
Measured: 36 weeks PMA
Incidence of oxygen dependency at 40 weeks PMA
Measured: 40 weeks PMA
Mortality rate
Measured: 28-days since birth and 36 weeks PMA
incidence of intraventricular hemorrhage (grade 3 or greater)
Measured: 28-days since birth
Incidence of retinopathy of prematurity (stage III or greater)
Measured: 40 weeks PMA (± 2 weeks)
Incidence of necrotizing enterocolitis (stage 2b or greater)
Measured: 40 weeks PMA (± 2 weeks)
Duration of PDA
Measured: 40 weeks PMA (± 2 weeks)
Duration of intubation
Measured: 36 weeks PMA
Duration of nasal continuous positive airway pressure (NCPAP) treatment
Measured: 40 weeks PMA (± 2 weeks)
Cumulative duration of oxygen use
Measured: 40 weeks PMA (± 2 weeks)
Incidence of adverse events
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Growth velocity
Measured: 40 weeks PMA (± 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se In Sung, Samsung Medical Center
- Investigators
- Se In Sung, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128191
- Sponsor's protocol ID
- 2013-07-129
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2014
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32539121
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02128191
- Acronym / sponsor ID
- 2013-07-129
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Keywords
- Patent ductus arteriosus, Ibuprofen, Bronchopulmonary dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral ibuprofen | Active comparator | Drug: Oral ibuprofenInitial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later |
| Normal saline | Placebo comparator | Drug: Normal salineInitial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm |
Who may qualify
- Ages
- 5 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral ibuprofenAlso: Brufen® syrup, Samil pharm. Co., Ltd.Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later | Drug | Oral ibuprofen |
| Normal salineAlso: Sodium chloride, Huons. Inc.Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm | Drug | Normal saline |
Primary outcome
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
Time frame: 36 weeks PMA
12 secondary outcomes
Incidence of moderate to severe BPD
Time frame: 36 weeks PMA
Incidence of oxygen dependency at 40 weeks PMA
Time frame: 40 weeks PMA
Mortality rate
Time frame: 28-days since birth and 36 weeks PMA
incidence of intraventricular hemorrhage (grade 3 or greater)
Time frame: 28-days since birth
Incidence of retinopathy of prematurity (stage III or greater)
Time frame: 40 weeks PMA (± 2 weeks)
Incidence of necrotizing enterocolitis (stage 2b or greater)
Time frame: 40 weeks PMA (± 2 weeks)
Duration of PDA
Time frame: 40 weeks PMA (± 2 weeks)
Duration of intubation
Time frame: 36 weeks PMA
Duration of nasal continuous positive airway pressure (NCPAP) treatment
Time frame: 40 weeks PMA (± 2 weeks)
Cumulative duration of oxygen use
Time frame: 40 weeks PMA (± 2 weeks)
Incidence of adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Growth velocity
Time frame: 40 weeks PMA (± 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32539121Sung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se In Sung, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral ibuprofen and Normal saline in people with Bronchopulmonary Dysplasia (BPD), run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) (time frame: 36 weeks PMA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.