Comparison of oral Ibuprofen and intravenous indomethacin for the treatment of patent ductus arteriosus

Comparison of oral Ibuprofen and intravenous indomethacin for the treatment of patent ductus arteriosus in preterm infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015111024977N1

Enrollment

Registered

2015-12-16

Start date

2014-08-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus. Patent ductus arteriosus

Interventions

Intervention 1: In the intervention group Type of treatment:Treatment with ibuprofen Dose: 10 mg per kg and then to 5 mg kg at 24 and 48 hours after birth. Intervention 2: In the comparison group Type

Treatment - Drugs

In the intervention group Type of treatment:Treatment with ibuprofen Dose: 10 mg per kg and then to 5 mg kg at 24 and 48 hours after birth

In the comparison group Type of treatment:Treatment with Indomethacin Dose: 0.2 milligrams per kilogram at 24 and 48 hours after birth

Eligibility

Sex/Gender

All

Age

1 Days to 31 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Gestational age between 29 weeks and six days to 35 weeks and six days; Between 1000 and 2500 gr birth weight; Age 72 to 120 hours after birth. Exclusion criteria:Congenital heart disease; Life-threatening infection; Liver failure; Severe intracranial hemorrhage.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Thrombocytopenia. Timepoint: 72 hours after intervention. Method of measurement: blood test.;Pulmonary hemorrhage. Timepoint: 72 hours after intervention. Method of measurement: Examination and chest radiography.;Increased creatinine. Timepoint: 72 hours after intervention. Method of measurement: blood test.;Increased bilirubin. Timepoint: 72 hours after intervention. Method of measurement: blood test.	—

Measure

Time frame

Thrombocytopenia. Timepoint: 72 hours after intervention. Method of measurement: blood test.;Pulmonary hemorrhage. Timepoint: 72 hours after intervention. Method of measurement: Examination and chest radiography.;Increased creatinine. Timepoint: 72 hours after intervention. Method of measurement: blood test.;Increased bilirubin. Timepoint: 72 hours after intervention. Method of measurement: blood test.

—

Secondary

Measure	Time frame
Closure of patent ductus arteriosus. Timepoint: 72 hours after intervention. Method of measurement: Using echocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Masoomeh Mohaqeqi Kamal

Qom university of medical sciences

hosseinmohaqeq@gmail.com+253 6633608

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026