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

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 15, 2021

Primary Completion Date

August 15, 2022

Study Completion Date

September 1, 2022

Conditions
Patent Ductus Arteriosus After Premature BirthPatent 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"

Trial Locations (1)

Unknown

Faculty of Medicine Ain Shams University, Cairo

All Listed Sponsors
lead

Nada Youssef

OTHER