Paracetamol in Patent Ductus Arteriosus

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Treatments: Acetaminophen; Ibuprofen

Criteria

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.