Skip to content

The Efficiency and Safety of Low Dose Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonate

The Efficiency and Safety of Low Dose Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonate

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241122001
Enrollment
128
Registered
2024-11-22
Start date
2021-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patent ductus arteriosus (PDA) is the common complication in prematurity. Intravenous indomethacin three doses is the effective medication for closure PDA but the complication about renal impairment and gastrointestinal(GI) problem should be aware. Low dose Indomethacin, patent ductus arteriosus, preterm

Interventions

Group 1 64 patients who received 2 doses of IV indomethacin (0.2 mg/kg/dose) , Group 2 64 patients who received 3 doses of IV indomethacin (0.2 mg/kg/dose)
Experimental Drug,Experimental Drug
Indomethacin Low dose,Indomethacin Normal dose

Sponsors

Chonburi hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 6 Days

Inclusion criteria

Inclusion criteria: 1.Preterm newborn less than 34 weeks or body weight less than 1,500 grams with age less than 6 days who had hemodynamically significant PDA (PDA size more than or equal 1.5 mm and the presence of reversal flow in the descending aorta or a Left Atrium: Aorta ratio 1.4:1 by echocardiogram)

Exclusion criteria

Exclusion criteria: 1.Major congenital anomalies such as cyanotic heart disease , Genetic disease 2.Abnormal renal anatomy 3.Life threatening sepsis 4.Necrotizing enterocolitis 5.Intraventricular hemorrhage 6.Creatinine > 1.5 mg/dL 7. platelet count < 100,000 /ml

Design outcomes

Primary

MeasureTime frame
Success closure rate of PDA at 72 hours and 7 days after closure PDA Report of echocardiogram

Secondary

MeasureTime frame
Repeat treatment -NEC, GI bleeding, Renal impairment 72 hours and 7 days after closure PDA Number of patients

Countries

Thailand

Contacts

Public ContactWasana Hongkan

Chonburi hospital

wasana.chon@cpird.in.th0816373849

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026