To treat or not to treat in ELGANs? – a monocentric retrospective data analysis

Background: In extremely preterm infants the ductus arteriosus, a primary physiological connection between the pulmonary vessel and the aorta, often remains patent after birth. This patency (PDA) may result in abnormal bloodflow between pulmonary and systemic circulation, contributing to an increased risk for complications such as bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL). Although PDA is a common situation in preterm infants, no mandatory consensus on the management regarding timing and treatment is committed yet.

Objective: The aim of this study was to investigate the outcome in preterm infants less than 28 weeks of gestation (ELGANs) in our center with an early-targeted approach of PDA-treatment. Furthermore we compared the outcome to recently published data from both, BeNeDuctus- trial and Baby-OSCAR-trial.

Methods: This monocentric retrospective analysis of patient data from the University hospital Jena included all ELGANs, admitted to our NICU between 2013 and 2023. Infants with congenital heart defects other than persistent foramen ovale (PFO) or atrial septum defect (ASD), other life-threatening conditions / genetic disorders, or therapy-dependent pulmonary hypertension (PPHN) were excluded from the analysis. Statistical analyses were made using the tidyverse package3 by RStudio (version 2022.02.1+461 "Prairie Trillium"). Ethical approval was obtained. Screening for PDA was done in all patients between 48-72h of life. Treatment was initiated if ductal diameter was>=1,5mm and slow unrestricted pattern.

Results: The study population included 94 ELGANs receiving early ibuprofen treatment. The median age was 26, 3 weeks (IQR: 25,3 – 27,5) and median birthweight 910g (IQR: 750g – 1049g). We found a lower incidence in the combined outcome of death or BPD (moderate to severe) (15%) and the single outcome parameters death (4%), BPD (8%) and NEC (9%) compared with the recent published data. Interestingly we also documented less usage of cointerventions, namely diuretics (28%) and steroids (41%). Patients with treatment initiation within the first three days of life had less BPD (4%) compared to those with initiation beyond the third day(12%). Over the past years, we saw an increased use of acetaminophen, especially for following courses of treatment. Since 2018, when a combined neonatal-cardiological assessment was established, no further operative ligation for PDA was required [1] [2] [3].

Conclusion: Analyzing our single-center data with early targeted treatment approach regarding patent ductus in ELGANs we face fairly low incidences of BPD and NEC as well as the combined outcome. Bearing in mind these retrospective data and BPD being a multifactorial disease, we see no current need to change our setting, especially when taking into account the potential adverse events of PDA-ligation or interventional closure.

Publication History

Article published online:
19 May 2025

• Literatur

• 1 Wickham H, Averick M, Bryan J. et al. Welcome to the tidyverse. J Open Source Softw 2019; 4: 1686
• 2 Hundscheid T, Onland W, Kooi EMW. et al. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med 2023; 388: 980-990
• 3 Gupta S, Subhedar NV, Bell JL. et al. Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med 2024; 390: 314-325