NCT01511887

Brief Summary

The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 13, 2012

Last Update Submit

January 19, 2012

Conditions

Patent Ductus Arteriosus

Keywords

Patent Ductus ArteriosusPDATerm newbornsIbuprofen

Outcome Measures

Primary Outcomes (2)

  • PDA closure after 1 week

    PDA closure after 1 week of treatment based on echocardiography

    1 weeks after treatment

  • PDA closure after two weeks

    PDA closure two weeks after treatment based on echocardiography

    2 weeks after treatment

Secondary Outcomes (1)

  • Drug side effects

    two weeks after treatment

Study Arms (2)

Oral Ibuprofen

EXPERIMENTAL

10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.

Drug: Oral Ibuprofen

No treatment

NO INTERVENTION

No treatment

Interventions

Oral IbuprofenDRUG

10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.

Also known as: Advil
Oral Ibuprofen

Eligibility Criteria

Age20 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term newborn (37 weeks of gestation or more)
  • Age between 20-28 days
  • confirmed diagnosis of PDA by echocardiography by pediatric cardiologist

You may not qualify if:

  • Asphyxia
  • Hemorrhage
  • Platelet count \< 150000
  • renal or gastrointestinal malformations
  • associated congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

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

  • Hamidreza Mahboobi, MD

    Hormozgan University of Medical Sciences (HUMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

IR(1)