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Clinical trial

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus of Preterm Infants - Randomised, Placebo-controlled Multicentre Trial

ID
Name
38/2018
Description
The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.
Trial arms
Trial start
2018-09-03
Estimated PCD
2024-01-01
Trial end
2024-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Paracetamol 10Mg/mL
Experimental drug
Arms:
Indomethacin 25mg/mL and Paracetamol10mg/mL, Pedea 5mg/mL and Paracetamol 10mg/mL
Other names:
Paracetamol Fresenius Kabi 10mg/mL infusion solution
0.45% Sodium Chloride
Placebo comparator
Arms:
Indomethacin 25mg/mL and 0.45 sodium chloride, Pedea 5mg/mL and 0.45 sodium chloride
Other names:
NATRIUMKLORID BRAUN 4,5 mg/mL infusion solution
Ibuprofen
Standard therapy
Arms:
Pedea 5mg/mL and 0.45 sodium chloride, Pedea 5mg/mL and Paracetamol 10mg/mL
Other names:
Pedea 5mg/mL injection solution
Indomethacin
Standard therapy
Arms:
Indomethacin 25mg/mL and 0.45 sodium chloride, Indomethacin 25mg/mL and Paracetamol10mg/mL
Other names:
Liometacen 50mg/2mL injection
Size
60
Primary endpoint
Ductal closure
Neonatal internsive care unit (NICU) stay up to 12 weeks
Eligibility criteria
Inclusion Criteria: * Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen therapy, are eligible to this trial. Exclusion Criteria: * severe malformation or suspected chromosomal defect * other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, randomized, placebo-controlled, double-blind, clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "Placebo, 0.45 % saline, is similar to paracetamol, both being clear liquids, so the staff will remain unaware which drug the patient receives. The study drug will be kept and prepared away from the neonatal intensive care unit, at the separate ward 55 office, in a locked cabinet. The study drug will be prepared by the research nurse, the pharmacist of the ward, or during nighttime, by a nurse who does not participate in the study patients' treatment in any way.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-06-23

1 organization

4 products

1 indication

Organization
University of Oulu
Product
Paracetamol
Indication
Patent Ductus Arteriosus
Product
0.45% Sodium Chloride
Product
Ibuprofen
Product
Indomethacin