Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

• Status: Suspended
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova; University of Padua
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• inborn neonates

• preterm neonates ≤ 31+ 6 days weeks gestation

• newborns with HsPDA

• parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

• Serum creatinine concentration greater than 1,5 mg/dl (132MMole/L)

• Urine output less than 1 ml/Kg/h

• Severe IVH (> grade II according to Volpe classification)

• Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate)

• Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals

• Thrombocyte count of less than 50.000/mm3

• Proved Sepsis

• Severe coagulopathy or liver failure

• Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0

• Known genetic or chromosomal disorders

• Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.