MedTrace Logo

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

NCT05493540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-28

No results posted yet for this study

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

Interventions

DRUG

Ibuprofen oral suspension

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Nada Youssef

    lead OTHER

Principal Investigators

  • Nada H Youssef · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-08-15
Completion
2022-09-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493540 on ClinicalTrials.gov