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

Primary Purpose

Patent Ductus Arteriosus

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

oral ibuprofen

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept 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

Sites / Locations

Zekai Tahir Burak Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intravenous ibuprofen

Oral ibuprofen

Arm Description

Extremely low birth weight patients receiving iv ibuprofen

Extremely low birth weight patients receiving oral ibuprofen

Outcomes

Primary Outcome Measures

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

To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment

Secondary Outcome Measures

Efficacy and Safety of Oral Versus Intravenous Ibuprofen

Evaluation of renal tolerance and complications

Full Information

NCT ID

NCT01261117

First Posted

November 29, 2010

Last Updated

August 8, 2011

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01261117

Brief Title

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

Official Title

Oral Versus Intravenous Ibuprofen Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Ductus Arteriosus

Keywords

Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intravenous ibuprofen

Arm Type

Active Comparator

Arm Description

Extremely low birth weight patients receiving iv ibuprofen

Arm Title

Oral ibuprofen

Arm Type

Active Comparator

Arm Description

Extremely low birth weight patients receiving oral ibuprofen

Intervention Type

Drug

Intervention Name(s)

oral ibuprofen

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Efficacy and Safety of Oral Versus Intravenous Ibuprofen

Description

Evaluation of renal tolerance and complications

Time Frame

Results will be identified in 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omer Erdeve

Organizational Affiliation

Zekai Tahir Burak Women's Health Research and Education Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Zekai Tahir Burak Maternity Teaching Hospital

City

Ankara

ZIP/Postal Code

06600

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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