Completed

Pharmacological Closure of Patent Ductus Arteriosus in Extreme Low Birth Weight Infants. A Comparison of Efficacy, Side Effects and Outcomes Between Indomethacin and Ibuprofen

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What is being tested

Ibuprofen

Drug
Who is being recruted

Congenital Abnormalities+13

+ Bronchopulmonary Dysplasia

+ Cardiovascular Diseases

Until 6 Months
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2007
See protocol details

Summary

Principal SponsorTaipei Medical University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2007

Actual date on which the first participant was enrolled.

The aims of this study are to compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants. We enrolled one hundred and ten ELBW infants who had clinically significant and echo-evidence patent ductus arteriosus were assigned into 2 groups, 56 received indomethacin (0.2 mg/kg, 0.1 mg/kg and 0.1 mg/kg in 24 hours interval) and 54 received ibuprofen (10 mg/kg, 5mg/kg and 5 mg/kg in 24 hours interval). Serum electrolytes, creatinine, renal function (urine output, glomerular filtration rate (GFR), fractional excretion of sodium and potassium, osmolar clearance and free water clearance), urinary PG excretion, pulmonary outcome and mortality were all evaluated.

Official TitlePharmacological Closure of Patent Ductus Arteriosus in Extreme Low Birth Weight Infants. A Comparison of Efficacy, Side Effects and Outcomes Between Indomethacin and Ibuprofen
NCT01758913
Principal SponsorTaipei Medical University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 6 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesBronchopulmonary DysplasiaCardiovascular DiseasesDuctus Arteriosus, PatentHeart Defects, CongenitalHeart DiseasesInfant, Newborn, DiseasesInfant, Premature, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration DisordersRespiratory Distress SyndromeRespiratory Tract DiseasesCardiovascular AbnormalitiesLung InjuryVentilator-Induced Lung Injury

Criteria

1 inclusion criteria required to participate
The selection criteria were: (1) preterm infants with birth weight <1000 g; 2) radiographic diagnosis of respiratory distress syndrome (RDS); (3) requirement of mechanical ventilation and (4) echocardiographic and clinical evidence of significant patent ductus arteriosus (PDA).
1 exclusion criteria prevent from participating
Exclusion criteria included: (1) evidence of infection or sepsis; 2) lethal congenital anomalies; (3) oliguria (< 1 ml/kg/h) and/or serum creatinine > 2.0 mg/dl and (4) low platelet count (< 50,000/mm3) or bleeding tendency.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Infant who was assigned to ibuprofen, an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours respectively as a course was given.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

John H. Stroger, Jr. Hospital of Cook County

Chicago, United StatesOpen John H. Stroger, Jr. Hospital of Cook County in Google Maps
CompletedOne Study Center