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Patent Ductus ArteriosusNCT03860428

Early Treatment Versus Expectant Management of PDA in Preterm Infants

A study testing Ibuprofen, Paracetamol and Expectant Management in people with Patent Ductus Arteriosus, run by Lviv National Medical University at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages Up to 3 days
Conditions the study is for
Patent Ductus Arteriosus
What is being tested?
Ibuprofen, Paracetamol and Expectant Management
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
1 siteUkraine
Study dates
15 Feb 2019to 20 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gestational age < 32 weeks
  • Birthweight <1500 g
  • Age less than 72 hours
  • PDA diameter > 1.5 mm
  • Signed informed consent obtained from both parents

Who cannot join

  • 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
Show all 10Show fewer
  • A serum creatinine concentration of > 110 μmol/L
  • Oliguria <1 ml/kg/h
  • Suspected/apparent NEC
  • Suspected/apparent lung hypoplasia

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

  • Lviv National Medical University

    Lviv, 79010

Other trials in Ukraine

About this study

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

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.

Being tested
Ibuprofen, Paracetamol, Expectant Management
Keywords
PDA, Ibuprofen, Paracetamol, Expectant management
Medical subject headings
Ductus Arteriosus, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuprofenDrug

    Also called Cyclooxygenase Inhibitor

    In the medical treatment arm the in-tention is to close the ductus arteriosus.

  • ParacetamolDrug

    Also called Infulgan, Acetaminophen

    In the medical treatment arm the in-tention is to close the ductus arteriosus.

  • Expectant ManagementOther

    Also called Conservative management

    Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.

Study groups in NCT03860428
Study groupRoleWhat they receive
Rectal ibuprofenActive 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
Receives: Drug: Ibuprofen
Intravenous paracetamolActive comparatorEarly treatment of PDA that starts within the first 3 days of life using intravenous paraceta-mol 15 mg/kg q6h for 3 days
Receives: Drug: Paracetamol
Expectant TreatmentSham 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.
Receives: Other: Expectant Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)

    Measured: 36 weeks PMA

Secondary outcomes (13)

  1. PDA re-opening rate

    PDA re-opening after echocardiographically documented closure

    Measured: Day 1 up to 3 month

  2. Closure rate of PDA within a week after the first and second course of pharmacological treatment

    Measured: Participants will be evaluated at the end of first and second course, at an expected avarage of 10 days of life

  3. The need for surgical ductus closure

    Measured: Day 1 up to 3 month

  4. Duration of any ventilation assist

    The ventilation assist time period

    Measured: Day 1 up to 3 month

  5. Duration of oxygen supplementation

    Days on supplement oxygen

    Measured: Day 1 up to 3 month

  6. Age of administration of full volume of enteral nutrition

    Measured: Day 1 up to 3 month

  7. Incidence of oliguria

    Measured: In the first 14 days of life

  8. Incidence of hypotension

    Measured: Day 1 up to 3 month

  9. Incidence of BPD

    Measured: 36 weeks PMA

  10. Mortality rate

    Measured: 36 weeks PMA

  11. Incidence of severe intraventricular hemorrhage

    Measured: 28-days since birth

  12. Incidence of necrotizing enterocolitis (Bell stage ≥ IIa)

    Measured: 36 weeks PMA

  13. Incidence of periventricular leukomalacia

    Measured: 36 weeks PMA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start15 Feb 2019
  3. Primary completion20 Jul 2021
  4. Study completion20 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860428
Sponsor's protocol ID
04011994
Status last verified
Apr 2022
First submitted
16 Feb 2019
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34147090

Questions about this trial

What is this clinical trial studying?

A study testing Ibuprofen, Paracetamol and Expectant Management in people with Patent Ductus Arteriosus, run by Lviv National Medical University at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) (time frame: 36 weeks PMA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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