NCT00485160

Brief Summary

The purpose of this study is to determine whether closure of the PDA in premature neonates using IV ibuprofen vs continuous IV indomethacin has different side effects, eg. effects on renal function, on blood flow velocity in the superior mesenteric artery, the anterior cerebral artery, and the renal artery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_3

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

February 1, 2002

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
Last Updated

July 21, 2011

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

July 20, 2011

Conditions

Patent Ductus Arteriosus

Keywords

Patent Ductus ArteriosusIndomethacinIbuprofenRenal effects

Outcome Measures

Primary Outcomes (1)

  • To show no differences in urine output and/or in serum creatinine between the treatment groups

    Up to one day after completion of therapy

Secondary Outcomes (1)

  • To show no other clinical differences, eg. NEC, IVH or ROP between the groups; to study doppler flow velocities to these areas; to correlate with BNP levels.

    Until end of primary hospitalization

Interventions

Continuous indomethacinDRUG
ibuprofenDRUG

Eligibility Criteria

Age36 Hours - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \< 1500 gm birth weight with PDA confirmed by echocardiography

You may not qualify if:

  • Additional congenital heart lesions
  • Significant congenital malformations
  • Documented infection
  • Thrombocytopenia (\<60,000)
  • IVH grade 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

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

  • Cathy Hammerman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

February 1, 2002

Study Completion

September 1, 2006

Last Updated

July 21, 2011

Record last verified: 2007-06

Locations

IL(1)