High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant
1 other identifier
interventional
70
1 country
1
Brief Summary
The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age \<29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedNovember 19, 2010
July 1, 2010
1.9 years
November 17, 2010
November 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful rate in closing PDA of ibuprofen administered at high or standard dose.
Between 84 and 96 hours of life
Secondary Outcomes (1)
Effectiveness of a second high dose ibuprofen course; correlation between peak plasma level of ibuprofen and PDA closure; mortality or BPD among survivors, incidence of ICH, PVL, ROP, NEC, sepsis, and length of stay in hospital.
Hospital discharge
Study Arms (1)
Infant treated with high dose ibuprofen
EXPERIMENTALInterventions
Treatment with high (20-10-10 mg/kg/day)or standard dose(10-5-5 mg/kg/day) ibuprofen
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Careggi University Hospital, Division of Neonatology
Florence, 50141, Italy
Related Publications (1)
Dani C, Vangi V, Bertini G, Pratesi S, Lori I, Favelli F, Ciuti R, Bandinelli A, Martano C, Murru P, Messner H, Schena F, Mosca F. High-dose ibuprofen for patent ductus arteriosus in extremely preterm infants: a randomized controlled study. Clin Pharmacol Ther. 2012 Apr;91(4):590-6. doi: 10.1038/clpt.2011.284. Epub 2011 Nov 16.
PMID: 22089267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carlo Dani, MD
University of Florence, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 19, 2010
Study Start
June 1, 2008
Primary Completion
May 1, 2010
Study Completion
October 1, 2010
Last Updated
November 19, 2010
Record last verified: 2010-07