Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02056223
Study type Interventional
Source University of Padua
Contact
Status Suspended
Phase Phase 2/Phase 3
Start date January 9, 2017
Completion date October 31, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Suspended NCT01852916 - NHFOV Versus NCPAP to Prevent Exubation Failure N/A
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Recruiting NCT03510169 - Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe N/A
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Completed NCT05038514 - The Effect of Music Therapy in COVID-19 Patients Given Prone Position N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Active, not recruiting NCT03808402 - The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Completed NCT01812681 - Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities N/A
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Not yet recruiting NCT01440868 - Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome N/A
Completed NCT01222247 - Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Phase 3