PGE2 metabolite levels and development of significant patent ductus arteriosus in preterm infants
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
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 |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 1 Day to 7 Days |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT07338370 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Abbasia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.