Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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The objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens for PDA treatment in a population of preterm newborns of gestational age (GA) \<31+6 weeks with respiratory distress syndrome (RDS) and HsPDA:

* Group A: experimental boluses of paracetamol at 15 mg/Kg four time a day for three consecutive days.
* Group B: standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.

The primary objective of the study is: to evaluate the efficacy of paracetamol versus standard ibuprofen regimen, by comparing the rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria)

The secondary objective of the study is: to evaluate the safety of the above 2 therapeutic regimens in term of incidence of transient renal impairment, intraventricular hemorrhage (IVH) or other bleeding disorders, necrotizing enterocolitis (NEC) and isolated bowel perforation (without signs of NEC), incidence of sign of liver toxicity.

Conditions

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Ductus Arteriosus Patent Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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paracetamol

Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days.

Group Type EXPERIMENTAL

Intravenous paracetamol

Intervention Type DRUG

15 mg/Kg every 6 hours for three days

Intravenous ibuprofen

Standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.

Group Type ACTIVE_COMPARATOR

Intravenous ibuprofen

Intervention Type DRUG

10 -5-5 mg/Kg once a day for three days

Interventions

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Intravenous paracetamol

15 mg/Kg every 6 hours for three days

Intervention Type DRUG

Intravenous ibuprofen

10 -5-5 mg/Kg once a day for three days

Intervention Type DRUG

Other Intervention Names

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Paracetamol i.v. Pedea i.v.

Eligibility Criteria

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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.

Minimum Eligible Age

36 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No