Skip to content

Closure of venous that remained patent from fetal duration

Prophylactic intravenous Indomethacin effect in decreasing symptomatic Patent Ductus Arteriosus (PDA) and assisted ventilation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201107117010N1
Enrollment
70
Registered
2011-10-17
Start date
2011-01-21
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. Persistent ductus arteriosus

Interventions

Intervention 1: Intervention group: Intravenous (IV) indomethacin at 2-12 first hours with dosage of 0.2mg\kg and then 0.1mg/kg after 24 and 48 hours. Intervention 2: Control group: without any inter
Treatment - Drugs
Intervention group: Intravenous (IV) indomethacin at 2-12 first hours with dosage of 0.2mg\kg and then 0.1mg/kg after 24 and 48 hours

Sponsors

Tabriz University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: birth in Alzehra hospital and gestational age equal or lower than 32 week; birth weight equal or between 800-1500g. Exclusion criteria: congenital anomaly; severe asphyxia; thrombocytopenia(plt1.8mg\dl; bleeding tendency; mother consumption of indomethacine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Decreasing symptomatic PDA (severity of PDA). Timepoint: 4 days. Method of measurement: Echocardiography.

Secondary

MeasureTime frame
Decreasing assisted ventilation. Timepoint: First 14 days of birth. Method of measurement: Visit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mahmood Samadi

Tabriz University of Medical Science, Pediatric Department

Samadima@tbzmed.ac.ir , Dr_samadi_pedcard@yahoo.com+98 41 1526 2280

Outcome results

None listed

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