Early Treatment Versus Expectant Management of PDA in Preterm Infants

NCT ID: NCT03860428

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2021-07-20

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.

Conditions

Patent Ductus Arteriosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rectal ibuprofen

Early 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

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

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

Intravenous paracetamol

Early treatment of PDA that starts within the first 3 days of life using intravenous paraceta-mol 15 mg/kg q6h for 3 days

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

Expectant Treatment

Expectant 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.

Group Type: SHAM_COMPARATOR

Expectant Management

Intervention Type: OTHER

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

Interventions

Ibuprofen

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

Intervention Type: DRUG

Paracetamol

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

Intervention Type: DRUG

Expectant Management

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

Intervention Type: OTHER

Other Intervention Names

Cyclooxygenase Inhibitor; Infulgan, Acetaminophen; Conservative management

Eligibility Criteria

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

• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lviv National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmytro Dobryanskyy

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmytro Dobryanskyy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

L'viv National Medical University

Locations

Lviv National Medical University

Lviv, , Ukraine

Countries

Ukraine

References

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.

Reference Type: DERIVED

PMID: 34147090 (View on PubMed)

Other Identifiers

04011994

Identifier Type: -

Identifier Source: org_study_id