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

Ain Shams University

Status: Enrolling

Conditions: Prostaglandins; Neonatal Prematurity; Patent Ductus Arteriosus in Preterm Infants

Treatments: Drug: Ibuprofen (Brufen®)

Study type: Observational

Funder types: Other

Identifiers

NCT07338370

MD143/2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm neonates with gestational age ≤ 32 weeks, admitted to the NICU and diagnosed with patent ductus arteriosus by echocardiography on day 3 of life.

Exclusion criteria

• Preterm neonates with evidence of any of the following will be excluded:

Chromosomal anomaly or Congenital malformations Progressive intraventricular hemorrhage Congenital heart defect other than PDA and/or patent foramen ovale Pulmonary hypertension with right to left shunt on PDA Contraindications to the use of Ibuprofen: [1] Urine output <1 mL/kg/hour during preceding 8 hours. Serum creatinine >1.6 mg/dL. Platelet count <50 000/mm3. Abnormal coagulation profile. Necrotizing enterocolitis (NEC) or intestinal perforation

Trial design

34 participants in 2 patient groups

group1, hemodynamically significant PDA

Description:

fulfilling the following criteria PDA measuring \> 1.5 mm and predominantly left-to-right shunt. LA/Ao ratio between 1.4 and 1.6 in moderate PDA and \>1.6 in large PDA. Left pulmonary artery (LPA) diastolic flow velocity of \>0.25 m/sec. Systemic hypo perfusion: absent or reversed diastolic flow in the Aorta 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

Treatment:

Drug: Ibuprofen (Brufen®)

group2, hemodynamically insignificant PDA

Description:

Spontaneous closure group by echocardiography