RecruitingNCT07338370

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


Sponsor

Ain Shams University

Enrollment

34 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 DayMax Age: 7 Days

Inclusion Criteria1

  • 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 Criteria2

  • 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

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Interventions

DRUGIbuprofen (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.


Locations(1)

Faculty of Medicine, Ain Shams, University

Cairo, Abbasia, Egypt

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NCT07338370