NCT00642330

Brief Summary

it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

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, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
Last Updated

March 25, 2008

Status Verified

March 1, 2008

Enrollment Period

2 months

First QC Date

March 17, 2008

Last Update Submit

March 24, 2008

Conditions

Patent Ductus Arteriosus

Keywords

patentductusarteriosusibuprofenprematureinfant

Outcome Measures

Primary Outcomes (1)

  • rate of ductal closure

Secondary Outcomes (1)

  • rate of side effects

Study Arms (2)

I

ACTIVE COMPARATOR
Drug: intravenous ibuprofen

O

ACTIVE COMPARATOR
Drug: oral ibuprofen

Interventions

oral ibuprofenDRUG

one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.

O
intravenous ibuprofenDRUG

one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.

I

Eligibility Criteria

Age48 Hours - 96 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • a gestational age \< 32 weeks
  • a birth weight \< 1500g
  • a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation
  • an echocardiographic evidence of left to right significant shunting PDA

You may not qualify if:

  • a right-to-left shunting
  • major congenital anomalies
  • IVH grade 3-4
  • a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and / or oozing from puncture sites)
  • a serum creatinine level \>140µmol/l, a serum urea nitrogen \> 14 µmol/l and a platelet count \< 60000/mm3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity and Neonatal Center

Tunis, 1007, Tunisia

Location

Related Publications (2)

  • Cherif A, Jabnoun S, Khrouf N. Oral ibuprofen in early curative closure of patent ductus arteriosus in very premature infants. Am J Perinatol. 2007 Jun;24(6):339-45. doi: 10.1055/s-2007-981853. Epub 2007 Jun 12.

    PMID: 17564958RESULT

  • Cherif A, Khrouf N, Jabnoun S, Mokrani C, Amara MB, Guellouze N, Kacem S. Randomized pilot study comparing oral ibuprofen with intravenous ibuprofen in very low birth weight infants with patent ductus arteriosus. Pediatrics. 2008 Dec;122(6):e1256-61. doi: 10.1542/peds.2008-1780.

    PMID: 19047225DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, PatentPremature Birth

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 25, 2008

Study Start

January 1, 2007

Primary Completion

March 1, 2007

Study Completion

December 1, 2007

Last Updated

March 25, 2008

Record last verified: 2008-03

Locations

TU(1)