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NCT Number: NCT02128191

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

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)

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Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

5 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral ibuprofen

Drug

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

Other names: Brufen® syrup, Samil pharm. Co., Ltd.

normal saline

Drug

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

Other names: Sodium chloride, Huons. Inc.

Primary outcomes

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

    Time frame: 36 weeks PMA

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 1, 2014
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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