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

NCT07338370 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Observational

Started

2026-01

Last updated

2026-01-13

Condition(s) studied

Neonatal PrematurityPatent Ductus Arteriosus in Preterm InfantsProstaglandins

Investigational drug(s) / intervention(s)

Ibuprofen (Brufen®) →

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.

Study summary

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

Eligibility

Sex

ALL

Min age

1 Day

Max age

7 Days

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

Primary outcome measure(s)

Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates. — initial PGE2 level on the first day of life and follow up the level after 3 days of treatment
correlating the initial levels of PGE2 with the significance of PDA

Trial sites (1)

Facility	City	Region	Status
Faculty of Medicine, Ain Shams, University	Cairo	Abbasia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07338370 on ClinicalTrials.gov ↗ ← All trials in Egypt