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

NCT07338370 | Recruiting

• 1 other identifier: MD143/2025
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Prematurity; Patent Ductus Arteriosus in Preterm Infants; Prostaglandins

Keywords

cerebral blood flow; neonates; PDA; preterms

Outcome Measures

Primary Outcomes (1)

• Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.

  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

Study Arms (2)

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®)

group2, hemodynamically insignificant PDA

Spontaneous closure group by echocardiography

Interventions

Ibuprofen (Brufen®) DRUG

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.

group1, hemodynamically significant PDA

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams, University

Cairo, Abbasia, 11517, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

PGE2

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Mennatallah Ayman ayman, masters

  Neonatal intensive care units (NICUs), Ain Shams University, Abbasia, Cairo, Egypt, 11517

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mennatallah Ayman ayman, MD student

CONTACT

+201004137614; menahayman@gmail.com

Sondos Ahmed

CONTACT

menahayman@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

EG (1)