NCT07338370

Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

Summary

prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.

Detailed description

Regulation of ductus arteriosus involves (PGE2), produced by the placenta and DA itself, that promotes ductal patency by relaxing smooth muscle. Prostaglandins are pluripotent lipid mediators derived from membrane glycerophospholipid metabolism. They are synthesized via a multienzyme cascade involving the actions of phospholipases and COX isoforms. Prostanoids, such as prostaglandin E2 and prostaglandin D2 metabolite (PGDM), are produced by various structural and inflammatory cells. Cyclooxygenase inhibitors restrict the PDA by inhibiting the prostaglandin synthase enzyme, which prevents arachidonic acid from converting to prostaglandin. Acetaminophen is also believed to inhibit the prostaglandin synthesis enzyme's peroxidase portion, resulting in the PDA narrowing. A significant decrease in serum PGE2 levels was observed following COX inhibitor treatment.

Conditions

• Neonatal Prematurity
• Patent Ductus Arteriosus in Preterm Infants
• Prostaglandins

Interventions

Type	Name	Description
DRUG	Ibuprofen (Brufen®)	Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days. Group 2 will be observed and follow up echocardiography and PGE2 level will be followed up 3 days after treatment or follow up in both groups.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Egypt