Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

NCT05493540 | Completed Phase 2

• 1 other identifier: MD 96 2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking. This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

Conditions

Patent Ductus Arteriosus After Premature Birth; Patent Ductus Arteriosus Conservative Management

Outcome Measures

Primary Outcomes (1)

• Incidence of PDA Closure by Echocardiography

  Compare the incidence of PDA closure assessed by Echocardiography during hospitalization between the two groups

  Hospital discharge (approximately 3 months unless death occurs first)

Secondary Outcomes (5)

• Incidence of death during hospitalization

  Hospital discharge (approximately 3 months unless death occurs first)

• Incidence of Necrotizing Enterocolitis (NEC)

  Hospital discharge (approximately 3 months unless death occurs first)

• Incidence of Bronchopulmonary dysplasia (BPD)

  Hospital discharge (approximately 3 months unless death occurs first)

• Incidence of Sepsis

  Hospital discharge (approximately 3 months unless death occurs first)

• Incidence of Intraventricular hemorrhage (IVH)

  Hospital discharge (approximately 3 months unless death occurs first)

Study Arms (2)

Medical treatment Group

ACTIVE COMPARATOR

40 preterm neonates will receive Ibuprofen oral suspension

Drug: Ibuprofen oral suspension

Placebo Group

PLACEBO COMPARATOR

40 preterm neonates will receive oral placebo

Drug: Placebo

Interventions

Ibuprofen oral suspension DRUG

The medical treatment group will receive oral Ibuprofen with conservative therapy in the form of fluid restriction, Positive End Expiratory Pressure (PEEP), and/or diuretics An additional course of Ibuprofen may be offered if there is: 1. Moderate/Severe PDA on Echocardiography 2. Prolonged ventilation or Increased ventilatory setting 3. Prolonged use of inotropes or vasopressors or escalating dose * Another form of treatment may be offered if the patient developed side effects from Ibuprofen

Also known as: Active treatment

Medical treatment Group

Placebo DRUG

Placebo Group will receive Oral Placebo and Conservative therapy in the form of fluid restriction, PEEP, and/or diuretics An Open-label option might be offered if there are concerns by attending physicians over the poor patient condition that might be attributed to persistent PDA: 1. Prolonged Ventilation or Escalating Ventilatory Setting 2. Prolonged Use Of Inotropes or Vasopressors or escalation of Doses Rescue therapy in the form of a course of oral ibuprofen may be offered: 1. After 5 days of recruitment 2. Moderate/Severe PDA on Echocardiography 3. Prolonged ventilation or Increased ventilatory setting 4. Prolonged use of inotropes or vasopressors or escalating dose - Another form of treatment may be offered if the patient developed side effects from Ibuprofen

Also known as: Conservative

Placebo Group

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≤ 34 weeks
• PDA Size \> 1.5 mm and predominantly left-to-right shunt
• One of the following:
• Signs of Pulmonary overflow: Left atrium/Aortic diameter ratio (LA/Ao), Left Ventricular End Diastolic Diameter (LVEDD).
• Signs of Systemic Hypo perfusion: Absent or Reversed diastolic flow in the aorta, celiac/mesenteric, or Anterior Cerebral Artery (ACA)/ Middle Cerebral Artery (MCA)

You may not qualify if:

• Chromosomal anomaly
• Congenital heart defect, other than PDA and/or patent foramen ovale
• Congenital or acquired gastrointestinal anomaly
• Previous episodes of Necrotizing enterocolitis (NEC) or intestinal perforation
• Active bleeding, especially intracranial or gastrointestinal hemorrhage
• Contraindications to the use of ibuprofen

Sponsors & Collaborators

• Nada Youssef: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nada H Youssef

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of pediatrics and neonatology

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 9, 2022
• Study Start: April 15, 2021
• Primary Completion: August 15, 2022
• Study Completion: September 1, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

EG (1)