CompletedPhase 2

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

Egypt80 participantsStarted 2021-04-15

Plain-language 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.

Who can participate

Age range1 Hour – 7 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

Incidence of PDA Closure by Echocardiography

Timeframe: Hospital discharge (approximately 3 months unless death occurs first)

Trial details

NCT IDNCT05493540

SponsorNada Youssef

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-15

View on ClinicalTrials.gov More Patent Ductus Arteriosus After Premature Birth trials