A Phase 2 interventional study of Ibuprofen oral suspension and Placebo in Patent Ductus Arteriosus After Premature Birth and Patent Ductus Arteriosus Conservative Management, sponsored by Nada Youssef. Completed at 1 site in Egypt. Open to participants aged 1 Hour to 7 Days. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Nada Youssef · Phase 2, Interventional, and Treatment
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.
A double-blinded, randomized, placebo-control non-inferiority trial was conducted in the neonatal intensive care unit (NICU) of Ain Shams University children's hospital, Cairo, Egypt.
Informed consent was taken from the parents or legal guardians before enrolment, after fully explaining to them the nature of the study. The approval of the Research Ethics Committee at Ain Shams University was also obtained.
All preterm neonates less than 34 weeks were assessed in the first 48 hours by clinical and echocardiographic examination by a cardiologist to detect PDA and exclude any congenital heart disease.
All neonates meeting the inclusion criteria will be randomized into one of two groups:
Medical treatment group and Placebo group. Targeted neonatal Echo was repeated after 5 days of the start of medical treatment by a neonatologist or a cardiologist to assess PDA closure.
After 7 days of intervention, open-label is offered to all patients with the option of another course for patients in the medical treatment group and Rescue therapy in the Placebo group.
The short-term morbidity is documented.
Withdrawal and replacement of individual subjects:
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with Nada Youssef as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 preterm neonates will receive Ibuprofen oral suspension
Drug: Ibuprofen oral suspension
40 preterm neonates will receive oral placebo
Drug: Placebo
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
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
Incidence of PDA Closure by Echocardiography
Compare the incidence of PDA closure assessed by Echocardiography during hospitalization between the two groups
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
Incidence of death during hospitalization
Compare the incidence of death during hospitalization between the two groups
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
Incidence of Necrotizing Enterocolitis (NEC)
Compare the incidence of NEC during hospitalization between the two groups by Bell's staging
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
Incidence of Bronchopulmonary dysplasia (BPD)
Compare the Incidence of BPD (needing supplemental oxygen at 28 days of life) during hospitalization between the two groups
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
Incidence of Sepsis
Compare the Incidence of sepsis during hospitalization between the two groups by positive blood culture.
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
Incidence of Intraventricular hemorrhage (IVH)
Compare the Incidence of IVH during hospitalization between the two groups by transcranial ultrasound
Time frame: Hospital discharge (approximately 3 months unless death occurs first)
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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