Early Treatment Versus Expectant Management of PDA in Preterm Infants

Patent Ductus Arteriosus Clinical Trial

Official title:

Randomized Non-inferiority Trial of Early Treatment Versus Expectant Management of Patent Ductus Arteriosus in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860428
• Other study ID #: 04011994
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

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