Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Brief Summary: It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation.


Options:
A: Inclusion Criteria:

* Ventilated term newborns and infants ≤ 60 days
* Expected time of artificial ventilation between 12 and 96 hours

Exclusion Criteria:

* Neuromuscular diseases
* Drug abuse of the mother (exclusion criteria for newborns)
* Known hypersensitivity to Ultiva® or Fentanyl-Janssen®
* Missing informed consent of the parents
* Participation in another clinical trial during the last 4 weeks before start of this trial
B: Inclusion Criteria:

1. Male or female preterm infants with no limitation of race.
2. Gestational age 25(+0) - 31(+6) weeks.
3. Age 24-72 hours.
4. Echocardiographic evidence of hemodynamically significant patent ductus arteriosus at the first 24-72 hours of life.

   The diagnosis of hemodynamically significant PDA requiring treatment will be made by echocardiographic demonstration of a ductal left-to-right shunt, with a left atrium-to-aortic root ratio \>1.3 or a ductal size \>1.5 mm and excluding the cases in which the closing flow pattern suggests a restrictive PDA.
5. Willingness of the parents/legally authorized representative/child to sign the Consent Informed Form.

Exclusion Criteria:

1. Outborn patients.
2. Major congenital anomalies, including but not limited to congenital heart defects, Down syndrome newborn and/or new born suffering from congenital anomalies diagnosed during the fetal period.
3. Known positive HIV and/or known positive Hepatitis C Virus newborn's mother.
4. Life threatening infection, complicated or not by multiple organ dysfunction and failure syndrome.
5. Fetal hydrops.
6. Pulmonary hypertension diagnosed in the first 24-48 hours of life by means of heart ultrasound when the presence of a right-to-left shunt through the foramen ovale or ductus arteriosus is demonstrated, or when the estimated pulmonary pressure, in terms of the tricuspid regurgitation jet, is greater than two-thirds of the systemic arterial pressure.
7. Grade 3 or 4 intraventricular haemorrhage (IVH).
8. Urine output \<1 ml/kg of body weight/h during a 24 h collection period or urine output \<0.5 ml/kg of body weight/h in case it is measured at 24 hours of life of newborn.
9. Serum creatinine concentration \> 1.5 mg/dl (132 μmol/l).
10. Platelet count \< 50,000/mm3.
11. Major bleeding, as revealed by hematuria, or blood in the endotracheal aspirate, gastric aspirate, or stools, or consistent oozing of blood from puncture sites.
12. Severe liver failure, defined as elevated liver enzymes (ALT/Glutamate-Pyruvate Transaminase and Aspartate aminotransferase/GOT) \> 2 times the upper boundary of the normal range. For this kind of population the following normal ranges will be considered \[Rosenthal, 1997\]:

    * ALT/Glutamate-pyruvate transaminase: 6-50 U/L
    * Aspartate aminotransferase/GOT: 35-140 U/L
13. Medical need of administering other Nonsteroidal Antiinflammatory Drug (NSAID) different from ibuprofen.
14. Participation to another trial involving any investigational drug.
C: Inclusion Criteria:

1. Gestational age ≤ 35 weeks
2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA
3. Urine output more than 1 ml/kg/hr
4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

   * Pulmonary stenosis
   * Anomalus in pulmonary venous drainage
   * Ventricular septal defect
2. Major congenital anomalies as hydrops fetalis
3. Low platelets count (less than 60, 000/mm3)
D: Inclusion Criteria:

* inborn neonates
* preterm neonates ≤ 32+ 6 days weeks gestation
* \< 72 hours of life
* newborns on MV
* within 24 hours from the beginning of MV administered through an endotracheal tube
* parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

* Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH \< 7.0
* Known genetic or chromosomal disorders
* Severe IVH (\> grade II according to Volpe classification (30))
* Need for post-operative analgesic therapy in the first week of life
* Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol

Answer: A