Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Preterm Infants' Paracetamol Study
Brief Summary: Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (\<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.


Options:
A: Arm Label: Early treatment; Type: EXPERIMENTAL; Interventions: Other: pharmacologic treatment of the PDA, Drug: NSAID | Arm Label: Conservative Treatment; Type: ACTIVE_COMPARATOR; Interventions: Other: no pharmacologic treatment of the PDA, Drug: NSAID | Intervention Type: OTHER; Name: pharmacologic treatment of the PDA; Assigned to Arm(s): Early treatment | Intervention Type: OTHER; Name: no pharmacologic treatment of the PDA; Assigned to Arm(s): Conservative Treatment | Intervention Type: DRUG; Name: NSAID; Assigned to Arm(s): Conservative Treatment, Early treatment
B: Arm Label: early ibuprofen; Type: EXPERIMENTAL; Interventions: Drug: Early ibuprofen | Arm Label: Late Ibuprofen expectant group (placebo); Type: OTHER; Interventions: Other: Late ibuprofen expectant group (placebo) | Intervention Type: DRUG; Name: Early ibuprofen; Assigned to Arm(s): early ibuprofen | Intervention Type: OTHER; Name: Late ibuprofen expectant group (placebo); Assigned to Arm(s): Late Ibuprofen expectant group (placebo)
C: Arm Label: Paracetamol effect on ductus; Type: EXPERIMENTAL; Interventions: Drug: paracetamol, Drug: 0.45 % saline solution | Arm Label: Paracetamol effect on pain; Type: EXPERIMENTAL; Interventions: Drug: paracetamol, Drug: 0.45 % saline solution | Intervention Type: DRUG; Name: paracetamol; Assigned to Arm(s): Paracetamol effect on ductus, Paracetamol effect on pain | Intervention Type: DRUG; Name: 0.45 % saline solution; Assigned to Arm(s): Paracetamol effect on ductus, Paracetamol effect on pain
D: Arm Label: Small ductus; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Large ductus ibuprofen; Type: EXPERIMENTAL; Interventions: Drug: Ibuprofen | Arm Label: Large ductus placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Large ductus ibuprofen | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Large ductus placebo

Answer: C