Please select the eligibility criteria that correspond 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: Inclusion Criteria:

This will be a prospective randomized, multi-center, controlled trial that will enroll infants delivered between 23 \& 0/7 - 27 \& 6/7 weeks gestation:

1. infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7 weeks) or 7-14 days old (if delivered between 26 \& 0/7 - 27 \& 6/7 weeks) and
2. have a "moderate size PDA" (defined as a PDA on echocardiogram that has at least one of the following criteria: internal ductus diameter ≥1.5 mm/kg (or PDA:LPA ratio ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus \<8 mm, LA/Ao ratio ≥1.5, left pulmonary artery diastolic (or mean) flow velocity \>0.2 (or \>0.42) m/sec, respectively, and/or reversed diastolic flow in the descending aorta)(13, 68, 69) and
3. are receiving respiratory support consisting of either mechanical ventilation, nasal CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

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   Exclusion Criteria:

   prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone administration within 24 hrs, urine output \< 1 ml/kg/h during the preceding 8 h, serum creatinine level \>1.6 mg/dl, platelet count \<50, 000/mm3, abnormal coagulation studies, or total bilirubin concentration (in mg/dL) \> 8 x weight (in kg)), chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior episode of necrotizing enterocolitis or intestinal perforation.

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B: Inclusion Criteria:

* Inborn patients at JHS hospitals (admitted to the NICU at JMH within the first 72 hrs of age
* BW 500-1250 grams
* 23-32 wks gestational age
* \> 1d but \< 14d of age.

Exclusion Criteria:

* Major congenital malformations
* Proven sepsis (positive blood culture)
* Contraindications to the use of Ibuprofen or Indomethacin
* Terminal condition, not expected to survive beyond 48 h
* Infants born excessively SGA(3 S.D. below the mean for GA)
* Infants with initial PDA presentation that is hemodynamically significant
C: Inclusion Criteria:

* preterm infants born \< 32 weeks gestational age

Exclusion Criteria:

* congenital malformation
* lethal disease
* chromosomal abnormality
* persistent pulmonary hypertension of a newborn
D: Inclusion Criteria:

* Gestational less than 28 weeks
* Postnatal age less than 12 hours

Answer: C