A Phase 1 interventional study of Paracetamol 10Mg/mL and 0.45% Sodium Chloride in Patent Ductus Arteriosus, sponsored by University of Oulu. Terminated at 4 sites in Finland. Open to participants aged Up to 4 Months. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by University of Oulu · Phase 1, Interventional, and Treatment
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.
Premature infants (born before 37 weeks gestational age) with patent ductus arteriosus (PDA) are the focus of the study since no trials on the additive efficacy of these two medications on the contraction of ductus arteriosus are available. Preterm infants who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen/indomethacin therapy, are eligible to this trial.
If the parents deny the consent, the patient will be treated according to the standard PDA treatment: three days' iv ibuprofen Pedea® 5mg/ml solution infusion (Oulu, Helsinki, Tartu) dosing: 10mg/kg + 5mg/kg + 5mg/kg (q24h); or three days' iv indomethacin (Turku) 0.2mg/kg + 0.1mg/kg + 0.1mg/kg (q24h). In case of any contraindications for ibuprofen/indomethacin, the treatment would be surgical ligation.
148 studies on the registry are indexed under Ductus Arteriosus, Patent; 18 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 82 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Intravenous (IV) ibuprofen 5mg/mL q 24h for 3 days, dosages: 10mg/kg + 5mg/kg + 5mg/kg and IV paracetamol 10mg/mL for 3 days: loading dose 20mg/kg, following 7.5mg/kg q 6h (up to12 doses)
Drug: Paracetamol 10Mg/mL · Drug: Ibuprofen
IV ibuprofen 5mg/mL q 24h for 3 days, dosages: 10mg/kg + 5mg/kg + 5mg/kg and NaCl 0.45% for 3 days, the same amount in mL as would have been given IV paracetamol
Drug: 0.45% Sodium Chloride · Drug: Ibuprofen
Intravenous (IV) indometahcin 25mg/mL q 24h for 3 days, dosages: 0.2mg/kg + 0.1mg/kg + 0.1mg/kg and IV paracetamol 10mg/mL for 3 days: loading dose 20mg/kg, following 7.5mg/kg q 6h (up to12 doses)
Drug: Paracetamol 10Mg/mL · Drug: Indomethacin
Intravenous (IV) indomethacin 25mg/mL q 24h for 3 days, dosages: 0.2mg/kg + 0.1mg/kg + 0.1mg/kg and NaCl 0.45% for 3 days, the same amount in mL as would have been given IV paracetamol
Drug: 0.45% Sodium Chloride · Drug: Indomethacin
Drug page: Acetaminophen
Experimental drug
Also known as: Paracetamol Fresenius Kabi 10mg/mL infusion solution
Placebo comparator
Also known as: NATRIUMKLORID BRAUN 4,5 mg/mL infusion solution
Standard therapy
Also known as: Pedea 5mg/mL injection solution
Standard therapy
Also known as: Liometacen 50mg/2mL injection
Ductal closure
Number of patients with ductal contraction without need for other PDA therapies
Time frame: Neonatal internsive care unit (NICU) stay up to 12 weeks
Need for ductal therapies
Given ductal therapies after the study drug
Time frame: NICU stay up to 12 weeks
Cardiac ultrasound findings
Ductal caliber (mm, mm/kg), LA/Ao ratio
Time frame: NICU stay up to 12 weeks
Duration of any ventilation assist
The ventilation assist time pediod
Time frame: NICU stay up to 12 weeks
Paracetamol serum levels
Measured paracetamol concentrations (mg/mL)
Time frame: Study drug period up to 4 days
Paracetamol side effects
Observed adverse events linked to study drug
Time frame: Study drug period plus 7 days, up to 10 days
Long term complications of prematurity
Moderate-to-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade 2-4, moderate to severe necrotizing enterocolitis, retinopathy of prematurity needing therapy
Time frame: Hospital stay up to 18 weeks
Other long-term morbidity, and mortality
Other severe diseases
Time frame: Hospital stay up to 18 weeks
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Plan to share: No
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Ibuprofen · Indomethacin