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

Information source: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patent Ductus Arteriosus

Intervention: oral ibuprofen (Drug)

Phase: N/A

Status: Completed

Sponsored by: Zekai Tahir Burak Women's Health Research and Education Hospital

Official(s) and/or principal investigator(s):
Omer Erdeve, Study Director, Affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Clinical Details

Official title: Oral Versus Intravenous Ibuprofen Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575

Secondary outcome: Efficacy and Safety of Oral Versus Intravenous Ibuprofen

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.

Eligibility

Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.

Criteria:

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

Locations and Contacts

Zekai Tahir Burak Maternity Teaching Hospital, Ankara 06600, Turkey
Additional Information

Starting date: January 2009
Last updated: August 8, 2011

Page last updated: August 23, 2015

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