Early Treatment Versus Expectant Management of PDA in Preterm Infants
Randomized Non-inferiority Trial of Early Treatment Versus Expectant Management of Patent Ductus Arteriosus in Preterm Infants
1 other identifier
interventional
208
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 16, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedApril 13, 2022
April 1, 2022
2.4 years
February 16, 2019
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
36 weeks PMA
Secondary Outcomes (13)
PDA re-opening rate
Day 1 up to 3 month
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
The need for surgical ductus closure
Day 1 up to 3 month
Duration of any ventilation assist
Day 1 up to 3 month
Duration of oxygen supplementation
Day 1 up to 3 month
- +8 more secondary outcomes
Study Arms (3)
Rectal ibuprofen
ACTIVE COMPARATOREarly treatment of PDA that starts within the first 3 days of life using rectal ibuprofen q24h for 3 days, dosages: 20 mg/kg + 10 mg/kg + 10 mg/kg
Intravenous paracetamol
ACTIVE COMPARATOREarly treatment of PDA that starts within the first 3 days of life using intravenous paraceta-mol 15 mg/kg q6h for 3 days
Expectant Treatment
SHAM COMPARATORExpectant PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA unless defi-nitely needed based of the predefined infant's condition.
Interventions
Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
In the medical treatment arm the in-tention is to close the ductus arteriosus.
In the medical treatment arm the in-tention is to close the ductus arteriosus.
Eligibility Criteria
You may qualify if:
- Gestational age \< 32 weeks
- Birthweight \<1500 g
- Age less than 72 hours
- PDA diameter \> 1.5 mm
- Signed informed consent obtained from both parents
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lviv National Medical University
Lviv, 79010, Ukraine
Related Publications (1)
Potsiurko S, Dobryanskyy D, Sekretar L. Patent ductus arteriosus, systemic NT-proBNP concentrations and development of bronchopulmonary dysplasia in very preterm infants: retrospective data analysis from a randomized controlled trial. BMC Pediatr. 2021 Jun 19;21(1):286. doi: 10.1186/s12887-021-02750-9.
PMID: 34147090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dmytro Dobryanskyy, MD, PhD
L'viv National Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 16, 2019
First Posted
March 4, 2019
Study Start
February 15, 2019
Primary Completion
July 20, 2021
Study Completion
July 20, 2021
Last Updated
April 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share