Skip to main content
OpenTrials
Completed

NCT Number: NCT03860428

Early Treatment Versus Expectant Management of PDA 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lviv National Medical University

Lviv, 79010, Ukraine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Other names: Cyclooxygenase Inhibitor

Paracetamol

Drug

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

Other names: Infulgan, Acetaminophen

Expectant Management

Other

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

Other names: Conservative management

Primary outcomes

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

    Time frame: 36 weeks PMA

Secondary outcomes

  1. PDA re-opening rate

    Time frame: Day 1 up to 3 month

    PDA re-opening after echocardiographically documented closure

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

    Time frame: 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

    Time frame: Day 1 up to 3 month

  4. Duration of any ventilation assist

    Time frame: Day 1 up to 3 month

    The ventilation assist time period

  5. Duration of oxygen supplementation

    Time frame: Day 1 up to 3 month

    Days on supplement oxygen

  6. Age of administration of full volume of enteral nutrition

    Time frame: Day 1 up to 3 month

  7. Incidence of oliguria

    Time frame: In the first 14 days of life

  8. Incidence of hypotension

    Time frame: Day 1 up to 3 month

  9. Incidence of BPD

    Time frame: 36 weeks PMA

  10. Mortality rate

    Time frame: 36 weeks PMA

  11. Incidence of severe intraventricular hemorrhage

    Time frame: 28-days since birth

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

    Time frame: 36 weeks PMA

  13. Incidence of periventricular leukomalacia

    Time frame: 36 weeks PMA

Sponsors and collaborators

Lead sponsor

Lviv National Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.