Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, Prospective Study
Brief Summary: The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.


Options:
A: 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
B: Inclusion Criteria:

* Birth weight below 1250 gram
* Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Urine output of less than 1 ml/kg/h during the preceding 8 h,
* Serum creatinine level \>1.6 mg/dl,
* Platelet count \<60,000/mm3,
* Liver failure,
* Hyperbilirubinemia requiring exchange transfusion
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis
C: 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.
D: Inclusion Criteria:

* Gestational age between 24 weeks and 27 weeks + 6 days
* Babies born to mother with either clinical chorioamnionitis, preterm and prelabor rupture of the membranes (PPROM), or preterm labor
* Written informed consent obtained before inclusion and randomization.

Exclusion Criteria:

* Babies born to mothers with birth weight below the 3th percentile
* PPROM before 22 weeks
* Major fetal anomaly or congenital malformation
* Mother refusal or inability to provide consent.

Answer: C