Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants

Oral Versus Intravenous Ibuprofen Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01261117

Enrollment

Registered

2010-12-16

Start date

2009-01-31

Completion date

2011-06-30

Last updated

2011-08-09

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

Conditions

Patent Ductus Arteriosus

Keywords

Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant

Brief summary

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

Detailed description

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.

Interventions

DRUGoral ibuprofen

oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Days to 7 Days

Healthy volunteers

Inclusion criteria

* Birth weight below 1000 gram * Diagnosed patent ductus arteriosis by Echocardiographic examination

Exclusion criteria

* Accompanied other congenital cardiac anomalies * Severe thrombocytopenia \< 60.000 * Severe intracranial bleeding (Grade 3-4) * Intestinal abnormality and necrotising enterocolitis

Design outcomes

Primary

Measure	Time frame	Description
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575	6 months	To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment

Secondary

Measure	Time frame	Description
Efficacy and Safety of Oral Versus Intravenous Ibuprofen	Results will be identified in 6 months	Evaluation of renal tolerance and complications

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026