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The impact of oral suspension of ibuprofen on closure of the arterial duct (between aorta and pulmonary artery) in full term neonates

Effect of oral ibuprofen on closure of the arterial duct (patent ductus arteriosus) in full term neonates

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138711291700N1
Enrollment
40
Registered
2009-05-25
Start date
2008-02-19
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 arteiosus. Patent ductus arteriosus

Interventions

Intervention 1: Intervention group: 10 mg/kg at the beginning and two 5 mg/kg with 24 hours intervals. Intervention 2: Control group: placebo.
Placebo
Intervention group: 10 mg/kg at the beginning and two 5 mg/kg with 24 hours intervals
Control group: placebo

Sponsors

Shiraz university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: having PDA in echocardigraphy, being symptomatic, age between 3 and 30 days old. Exclusion criteria: having ductal dependent congenital heart disease, pulmonary artery hypertension with pressure gradient>40mmHg, renal failure with creatinine>1.8, fulminant sepsis and thrombocytopenia with platelet count <50000.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Closing of the PDA. Timepoint: 4th and 14th days after the first dose of treatment. Method of measurement: echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amouzegar

Shiraz university of medical sciences

tehranim@sums.ac.ir+98 71 1647 4298

Outcome results

None listed

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