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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128191
Recruitment Status : Active, not recruiting
First Posted : May 1, 2014
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Se In Sung, 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)

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia (BPD) Drug: Oral ibuprofen Drug: Normal saline Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Active Comparator: Oral ibuprofen
Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later
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
Other Name: Brufen® syrup, Samil pharm. Co., Ltd.

Placebo Comparator: Normal saline
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
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
Other Name: Sodium chloride, Huons. Inc.




Primary Outcome Measures :
  1. Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]

Secondary Outcome Measures :
  1. Incidence of moderate to severe BPD [ Time Frame: 36 weeks PMA ]
  2. Incidence of oxygen dependency at 40 weeks PMA [ Time Frame: 40 weeks PMA ]
  3. Mortality rate [ Time Frame: 28-days since birth and 36 weeks PMA ]
  4. incidence of intraventricular hemorrhage (grade 3 or greater) [ Time Frame: 28-days since birth ]
  5. Incidence of retinopathy of prematurity (stage III or greater) [ Time Frame: 40 weeks PMA (± 2 weeks) ]
  6. Incidence of necrotizing enterocolitis (stage 2b or greater) [ Time Frame: 40 weeks PMA (± 2 weeks) ]
  7. Duration of PDA [ Time Frame: 40 weeks PMA (± 2 weeks) ]
  8. Duration of intubation [ Time Frame: 36 weeks PMA ]
  9. Duration of nasal continuous positive airway pressure (NCPAP) treatment [ Time Frame: 40 weeks PMA (± 2 weeks) ]
  10. Cumulative duration of oxygen use [ Time Frame: 40 weeks PMA (± 2 weeks) ]
  11. Incidence of adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  12. Growth velocity [ Time Frame: 40 weeks PMA (± 2 weeks) ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128191


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Se In Sung, M.D. Samsung Medical Center

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Responsible Party: Se In Sung, M.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02128191     History of Changes
Other Study ID Numbers: 2013-07-129
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Se In Sung, Samsung Medical Center:
Patent ductus arteriosus
Ibuprofen
Bronchopulmonary dysplasia

Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ductus Arteriosus, Patent
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action