Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03860428
Other study ID # 04011994
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date July 20, 2021

Study information

Verified date April 2022
Source Lviv National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile. Recently, expectant approach has becoming more popular, although there is not enough evidence to support it. The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter > 1.5 mm) at a postnatal age of < 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date July 20, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Days
Eligibility Inclusion Criteria: - Gestational age < 32 weeks - Birthweight <1500 g - Age less than 72 hours - PDA diameter > 1.5 mm - Signed informed consent obtained from both parents Exclusion Criteria: - Birthweight = 1500 g and/or gestation age = 32 weeks - Lack of informed consent of the parents - Congenital heart defect, other than PDA and/or patent foramen ovale (PFO) - The presence of a clinically apparent hemorrhagic syndrome - Any intraventricular hemorrhage (IVH) in the first 48 hours or IVH grade 3-4 - A platelet count of < 50,000/mm3 - A serum creatinine concentration of > 110 µmol/L - Oliguria <1 ml/kg/h - Suspected/apparent NEC - Suspected/apparent lung hypoplasia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ibuprofen
In the medical treatment arm the in-tention is to close the ductus arteriosus.
Paracetamol
In the medical treatment arm the in-tention is to close the ductus arteriosus.
Other:
Expectant Management
Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.

Locations

Country Name City State
Ukraine Lviv National Medical University Lviv

Sponsors (1)

Lead Sponsor Collaborator
Lviv National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) 36 weeks PMA
Secondary PDA re-opening rate PDA re-opening after echocardiographically documented closure Day 1 up to 3 month
Secondary Closure rate of PDA within a week after the first and second course of pharmacological treatment Participants will be evaluated at the end of first and second course, at an expected avarage of 10 days of life
Secondary The need for surgical ductus closure Day 1 up to 3 month
Secondary Duration of any ventilation assist The ventilation assist time period Day 1 up to 3 month
Secondary Duration of oxygen supplementation Days on supplement oxygen Day 1 up to 3 month
Secondary Age of administration of full volume of enteral nutrition Day 1 up to 3 month
Secondary Incidence of oliguria In the first 14 days of life
Secondary Incidence of hypotension Day 1 up to 3 month
Secondary Incidence of BPD 36 weeks PMA
Secondary Mortality rate 36 weeks PMA
Secondary Incidence of severe intraventricular hemorrhage 28-days since birth
Secondary Incidence of necrotizing enterocolitis (Bell stage = IIa) 36 weeks PMA
Secondary Incidence of periventricular leukomalacia 36 weeks PMA
See also
  Status Clinical Trial Phase
Recruiting NCT04986839 - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial Phase 2/Phase 3
Recruiting NCT03648437 - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus Phase 1
Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Completed NCT00217191 - Ibuprofen and Renal Function in Premature Infants Phase 4
Not yet recruiting NCT02894970 - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.