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

NCT02128191 | Completed Phase 2 DMC

• 1 other identifier: 2013-07-129
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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)

Conditions

Bronchopulmonary Dysplasia (BPD)

Keywords

Patent ductus arteriosus; Ibuprofen; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

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

  36 weeks PMA

Secondary Outcomes (12)

• Incidence of moderate to severe BPD

  36 weeks PMA

• Incidence of oxygen dependency at 40 weeks PMA

  40 weeks PMA

• Mortality rate

  28-days since birth and 36 weeks PMA

• incidence of intraventricular hemorrhage (grade 3 or greater)

  28-days since birth

• Incidence of retinopathy of prematurity (stage III or greater)

  40 weeks PMA (± 2 weeks)

Study Arms (2)

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

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

Drug: Normal saline

Interventions

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

Also known as: Brufen® syrup, Samil pharm. Co., Ltd.

Oral ibuprofen

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

Also known as: Sodium chloride, Huons. Inc.

Normal saline

Eligibility Criteria

• Age: 5 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32539121 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Ductus Arteriosus, Patent

Interventions

Ibuprofen; Long-Term Synaptic Depression; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Se In Sung, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: May 1, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)