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
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