PGE2 metabolite levels and development of significant patent ductus arteriosus in preterm infants
Official title: Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
Run by Ain Shams University · NCT07338370 · Data updated 2026-11-12
This study will see if blood levels of a prostaglandin E2 metabolite predict which preterm babies (≤32 weeks) develop a hemodynamically significant patent ductus arteriosus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbasia) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07338370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm neonates born at or before 32 weeks gestation who are admitted to the participating NICU and have PDA diagnosed by echocardiography on day 3 of life are eligible if they do not meet exclusion criteria.
✕Probably not a fit
Infants with chromosomal anomalies, major congenital malformations, progressive intraventricular hemorrhage, other congenital heart defects, NEC or intestinal perforation, pulmonary hypertension with right-to-left shunt, or contraindications to ibuprofen (including severe renal dysfunction, low urine output, thrombocytopenia, or coagulopathy) are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort of preterm neonates (≤32 weeks) admitted to the NICU and diagnosed with PDA by echocardiography on day 3 of life. Blood samples will be collected to measure prostaglandin E2 metabolite levels and correlated with echocardiographic and clinical signs of a hemodynamically significant PDA. Infants who receive standard medical management (for example, ibuprofen) will have PGE2 metabolite changes recorded before and after treatment. Clinical outcomes such as PDA closure and short-term complications will be tracked alongside biomarker levels.
Why it matters
Potential benefit: If successful, this could help clinicians identify which preterm infants are at high risk for a clinically important PDA and guide earlier or more targeted treatment.
How similar studies have gone: Prior work has shown serum PGE2 levels fall after COX-inhibitor treatment and links between prostaglandin signaling and PDA exist, but using PGE2 metabolite measurements as a predictive clinical biomarker remains relatively unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Faculty of Medicine, Ain Shams, University
Cairo, Abbasia, Egypt Recruiting
Study contacts
- Principal investigator: Mennatallah Ayman ayman, masters — Neonatal intensive care units (NICUs), Ain Shams University, Abbasia, Cairo, Egypt, 11517
- Study coordinator: Mennatallah Ayman ayman, MD student
- Email: menahayman@gmail.com
- Phone: +201004137614
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.