Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 09/30/2019 |
| Eerste ingediend: | 02/02/2014 |
| Geschatte inschrijving ingediend: | 02/03/2014 |
| Eerst geplaatst: | 02/04/2014 |
| Laatste update ingediend: | 10/29/2019 |
| Laatste update geplaatst: | 11/03/2019 |
| Werkelijke startdatum van het onderzoek: | 01/08/2017 |
| Geschatte primaire voltooiingsdatum: | 10/30/2019 |
| Geschatte voltooiingsdatum van het onderzoek: | 10/30/2019 |
Conditie of ziekte
Interventie / behandeling
Drug: paracetamol
Drug: Intravenous ibuprofen
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: paracetamol Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days. | Drug: paracetamol 15 mg/Kg every 6 hours for three days |
| 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 |
Geschiktheidscriteria
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| 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. |
Resultaat
Primaire uitkomstmaten
1. PDA pharmacological closure [Partecipants will be evaluated at the end of first and second course, at an expected avarage of 8 days of life (DOL)]
Secundaire uitkomstmaten
1. Oliguria [In the first 14 days of life]
Andere uitkomstmaten
1. Necrotizing enterocolitis (NEC) [In the first 14 days of life]
2. Intraventricular haemorrhage (IVH) or death [Within 28 days of life]
