Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants. (PARIDA)
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|ClinicalTrials.gov Identifier: NCT02056223|
Recruitment Status : Suspended (We enrolled only 53 patients)
First Posted : February 5, 2014
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ductus Arteriosus Patent Respiratory Distress Syndrome||Drug: Intravenous paracetamol Drug: Intravenous ibuprofen||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.|
|Actual Study Start Date :||January 9, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days.
Drug: Intravenous paracetamol
15 mg/Kg every 6 hours for three days
Other Name: Paracetamol i.v.
Active Comparator: Intravenous ibuprofen
Standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.
Drug: Intravenous ibuprofen
10 -5-5 mg/Kg once a day for three days
Other Name: Pedea i.v.
- PDA pharmacological closure [ Time Frame: Partecipants will be evaluated at the end of first and second course, at an expected avarage of 8 days of life (DOL) ]The rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria) in paracetamol versus ibuprofen group
- Oliguria [ Time Frame: In the first 14 days of life ]Rate of oliguria defined as a reduction on urine output less than 1ml/Kg/h,
- Necrotizing enterocolitis (NEC) [ Time Frame: In the first 14 days of life ]Rate of NEC in the paracetamol and ibuprofen group
- Intraventricular haemorrhage (IVH) or death [ Time Frame: Within 28 days of life ]Rate of intraventricular haemorrhage (IVH) or death within 28 days of life (composite outcome).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056223
|NICU, Women's and Children's Health Department, Azienda Ospedaliera-University of Padua|
|Padua, Italy, 35128|
|Principal Investigator:||Paola Lago, MD||Women's and Children's Health Department- AO- University of Padua|