Last updated: October 16, 2024
Sponsor: University of Oulu
Overall Status: Terminated
Phase
1
Condition
Heart Defect
Treatment
0.45% Sodium Chloride
Paracetamol 10Mg/mL
Indomethacin
Clinical Study ID
NCT03648437
38/2018
Ages < 4 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have ahemodynamically significant PDA and who, according to the decision of the attendingclinician, need ibuprofen therapy, are eligible to this trial.
Exclusion
Exclusion Criteria:
severe malformation or suspected chromosomal defect
other very severe life-threatening disease (e.g. very severe birth asphyxia orpersistent pulmonary hypertension, etc.)
Study Design
Total Participants: 22
Treatment Group(s): 4
Primary Treatment: 0.45% Sodium Chloride
Phase: 1
Study Start date:
September 03, 2018
Estimated Completion Date:
October 04, 2024
Study Description
Connect with a study center
Tartu University Hospital
Tartu,
EstoniaSite Not Available
Helsinki Univeristy Central Hospital
Helsinki,
FinlandSite Not Available
Department of Pediatrics, Oulu University Hospital
Oulu, 90014
FinlandSite Not Available
Tampere University Hospital
Tampere,
FinlandSite Not Available
Turku University Hospital
Turku,
FinlandSite Not Available
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