Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Brief Summary: The investigators propose the present study with the following aims:

* to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only when symptoms of a hemodynamically significant PDA are present in the evolution of bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure during the first 28 days
* to determine whether early PDA treatment with ibuprofen will be superior to late treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for PDA ligation and incidence of major complications of prematurity.

Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the first 28 days of age vs. late pharmacologic treatment with ibuprofen.

Outcome variables: The primary outcome of this study is the number of days spent on supplemental oxygen by each infant during the first 28 days.

Other outcomes to be determined between groups include:

* Mortality
* Other respiratory variables: total days on supplemental oxygen, days on mechanical ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.
* Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need for high frequency ventilation, pulmonary hypertension
* Efficacy of PDA closure: number of courses of medication required, need for ligation
* Other neonatal complications: intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)
* Time to achieving full enteral feedings, time to regain birth weight, weight at discharge.
* Length of hospital stay


Options:
A: Arm Label: ibuprofen group; Type: EXPERIMENTAL; Interventions: Drug: ibuprofen | Arm Label: paracetamol group; Type: EXPERIMENTAL; Interventions: Drug: paracetamol | Intervention Type: DRUG; Name: ibuprofen; Assigned to Arm(s): ibuprofen group | Intervention Type: DRUG; Name: paracetamol; Assigned to Arm(s): paracetamol group
B: Arm Label: Infant treated with high dose ibuprofen; Type: EXPERIMENTAL; Interventions: Drug: Ibuprofen | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): Infant treated with high dose ibuprofen
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: I; Type: ACTIVE_COMPARATOR; Interventions: Drug: intravenous ibuprofen | Arm Label: O; Type: ACTIVE_COMPARATOR; Interventions: Drug: oral ibuprofen | Intervention Type: DRUG; Name: oral ibuprofen; Assigned to Arm(s): O | Intervention Type: DRUG; Name: intravenous ibuprofen; Assigned to Arm(s): I

Answer: C