Effects of two different brands of ibuprofen on ductus arteriosus closure

A clinical trial comparing the effects of two different brands of ibuprofen (Pedea and Ibuprofen) on ductus arteriosus closure in premature infants with patent ductus arteriosus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140519017756N48

Enrollment

160

Registered

2023-05-15

Start date

2023-06-05

Completion date

Unknown

Last updated

2023-05-29

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: Intervention group 1 (French Ibuprofen/Pedea): Ibuprofen from the French pharmaceutical company ORPHAN, Pedea brand, will be injected intravenously at doses of 10 mg/kg on the first da

Eligibility

Sex/Gender

All

Age

3 Days to 15 Days

Inclusion criteria

Inclusion criteria: Preterm newborn A size of patent ductus arteriosus that responds to drug therapy Gestational age of 32 weeks or more Birth weight 1500 grams and less Age between 3 and 15 days

Exclusion criteria

Exclusion criteria: Presence of underlying heart diseases Major congenital anomalies Life-threatening sepsis Renal failure Pulmonary hemorrhage Thrombocytopenia below 60,000/mm3

Design outcomes

Primary

Measure	Time frame
Ductus arteriosus closure. Timepoint: Prior to treatment initiation and three days post-treatment completion. Method of measurement: Echocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Taghizadegan

Birjand University of Medical Sciences

taghizadem98@gmail.com+98 56 3223 1580

Outcome results

None listed

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