80
Participants
Start Date
April 15, 2021
Primary Completion Date
August 15, 2022
Study Completion Date
September 1, 2022
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"
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"
Faculty of Medicine Ain Shams University, Cairo
Nada Youssef
OTHER