Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial
Brief Summary: The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth.

The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".


Options:
A: 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
B: 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
C: 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)
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: B