NCT01261117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

November 1, 2010

Enrollment Period

2.2 years

First QC Date

November 29, 2010

Last Update Submit

August 8, 2011

Conditions

Patent Ductus Arteriosus

Keywords

Patent ductus arteriosisİbuprofenExtremely Low Birth Weigh infant

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • Efficacy and Safety of Oral Versus Intravenous Ibuprofen

    Results will be identified in 6 months

Study Arms (2)

intravenous ibuprofen

ACTIVE COMPARATOR

Extremely low birth weight patients receiving iv ibuprofen

Drug: oral ibuprofen

Oral ibuprofen

ACTIVE COMPARATOR

Extremely low birth weight patients receiving oral ibuprofen

Drug: oral ibuprofen

Interventions

oral ibuprofenDRUG

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

Oral ibuprofenintravenous ibuprofen

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Omer Erdeve

    Zekai Tahir Burak Women's Health Research and Education Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 16, 2010

Study Start

January 1, 2009

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

August 9, 2011

Record last verified: 2010-11

Locations

TU(1)