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

January 3, 2026 updated by: Ain Shams University
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11517
        • Recruiting
        • Faculty of Medicine, Ain Shams, University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1, hemodynamically significant PDA
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
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.
group2, hemodynamically insignificant PDA
Spontaneous closure group by echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
Time Frame: 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
initial PGE2 level on the first day of life and follow up the level after 3 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Mennatallah Ayman ayman, masters, Neonatal intensive care units (NICUs), Ain Shams University, Abbasia, Cairo, Egypt, 11517

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD143/2025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Prematurity

Clinical Trials on Ibuprofen (Brufen®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe