Mortality and clinical outcomes in preterm infants with patent ductus arteriosus according to pharmacological treatment or expectant management: a retrospective cohort study

Q: What are the key findings of this study?

Pharmacological treatment of patent ductus arteriosus was not independently associated with in-hospital mortality compared to expectant management after multivariable adjustment (HR 2.25, p=0.09).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Hemodynamically significant patent ductus arteriosus (PDA) in preterm infants (n=156). Intervention: Pharmacological treatment (intravenous ibuprofen or paracetamol) vs. Expectant management (no pharmacological treatment for PDA). Primary outcome: Mortality before hospital discharge (HR 2.25, 95% CI 0.86-5.88, p=0.09).

Q: What does this research mean for the field?

Pharmacological treatment of patent ductus arteriosus is not independently associated with in-hospital mortality compared with expectant management in preterm infants after multivariable adjustment. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Javier Torres-Muñoz; Diana María Pérez Manrique; Lesly Georjany Escobar Gordillo; Angie M. G. Alomia; Julián Torres-Figueroa

doi:10.3389/fped.2026.1952588

October 8, 2026Frontiers in PediatricsOpen Access

Mortality and clinical outcomes in preterm infants with patent ductus arteriosus according to pharmacological treatment or expectant management: a retrospective cohort study

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Key result

Pharmacological PDA treatment shows no independent association with in-hospital mortality compared with expectant management.

HR 2.25
95% CI 0.86-5.88
P=0.09
n=156

Figures

Why the study?

Patent ductus arteriosus is frequent in preterm newborns, and its optimal management remains controversial. This study evaluated the association between pharmacological treatment and mortality in preterm infants.

Does pharmacological treatment with ibuprofen or paracetamol reduce in-hospital mortality compared to expectant management in preterm infants with hemodynamically significant patent ductus arteriosus?

Key Points

To evaluate the association between pharmacological treatment of patent ductus arteriosus and mortality in preterm infants compared with expectant management.
Retrospective cohort study of 156 preterm infants (<32 weeks or <1,500 g) evaluated across two institutions between 2023 and 2024.
Infants were categorized into expectant management without pharmacological therapy (n = 127) or pharmacological treatment with ibuprofen and/or paracetamol (n = 29).
Assessed mortality using Kaplan–Meier curves and multivariable Cox proportional hazards regression adjusting for gestational age, birth weight, and sepsis.
Unadjusted mortality occurred in 72.4% (21/29) of infants in the treatment group compared with 7.8% (10/127) in the expectant group (p < 0.01; unadjusted HR: 4.01; 95% CI: 1.67–9.63; p = 0.002).
After multivariable adjustment, pharmacological treatment was not independently associated with mortality (HR: 2.25; 95% CI: 0.86–5.88; p = 0.09).
Birth weight remained independently associated with lower mortality (HR: 0.997; 95% CI: 0.995–0.999; p = 0.020), while sepsis showed no significant association.

Study Design

Type

Cohort (n=156)

Multicenter

Yes

Structured PICO

Does pharmacological treatment with ibuprofen or paracetamol reduce in-hospital mortality compared to expectant management in preterm infants with hemodynamically significant patent ductus arteriosus?

P

Population

156 preterm infants (26-32.8 weeks gestation or birth weight <1,500 g, 55.1% female) with hemodynamically significant patent ductus arteriosus across two neonatal intensive care units in Cali, Colombia, followed until hospital discharge.

E

Exposure

Pharmacological treatment for PDA (n=29) administered according to institutional protocols at diagnosis (median initiation age 8 days, IQR 5-12): either intravenous ibuprofen (10 mg/kg on day 1, followed by 5 mg/kg on days 2 and 3) or intravenous paracetamol (15 mg/kg per dose every 6 hours for 3 days).

C

Comparator

Expectant management (n=127), defined as no pharmacological treatment for PDA (neither group underwent surgical or transcatheter PDA closure).

O

Outcome

Mortality before hospital dischargehard clinical

Main Result

Hazard Ratio: 2.25 (95% CI 0.86–5.88)

Absolute Event Rate: 72.4% vs 7.8%

p-value: p=0.09

Expectant management of hemodynamically significant PDA in preterm infants (26-32 weeks) was not associated with increased mortality or morbidity compared with pharmacological closure, supporting conservative management strategies.

Limitations

Retrospective cohort design limiting causal inference
Substantial baseline differences between groups and confounding by indication (treated infants had lower gestational age and birth weight)
Excluded extremely preterm newborns (<26 weeks gestation), limiting generalizability to this subgroup
Limited number of mortality events (31 deaths among 156 infants) relative to covariates in the multivariable Cox model, risking overfitting and imprecision
Proportion of infants receiving ibuprofen versus paracetamol and specific causes of death were not systematically recorded
Retrospective design limits causal inference and does not exclude residual confounding from unmeasured clinical severity variables
Substantial confounding by indication (pharmacologically treated infants had significantly lower gestational age and birth weight)
Results are not directly extrapolable to extremely preterm newborns (<26 weeks gestational age) who were excluded
Small number of primary outcome events (31 deaths) with five covariates in the multivariable Cox model may have resulted in overfitting and imprecision
Specific proportions of ibuprofen versus paracetamol use and exact causes of death were not systematically collected

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Implication

Pharmacological PDA treatment was not independently associated with mortality; leaves open optimal management strategy in preterm infants pending randomized trials.

Abstract

Introduction Patent ductus arteriosus (PDA) is frequent in preterm newborns and its management remains controversial. The objective was to evaluate the association between pharmacological treatment of PDA and mortality in preterm infants. Methods Retrospective cohort study. A sample size of 154 patients was estimated. Comparisons were performed using the Chi-square test for qualitative variables, and the Mann–Whitney test for continuous variables. Survival analysis was performed using the Kaplan–Meier curve and log-rank test. Cox regression models were used to estimate Hazard ratios (HR) with 95% confidence intervals (95% CI). Results A total of 156 patients were included. In the survival analysis, Kaplan–Meier curves showed a lower probability of survival in the treated group. In the Cox proportional hazards model, pharmacological treatment was not independently associated with mortality (HR: 2.25; 95% CI: 0.86–5.88; p = 0.09). Birth weight was independently associated with a lower mortality hazard rate (HR: 0.997; 95% CI: 0.995–0.999; p = 0.020). No significant associations were observed with sepsis. Conclusion Expectant management was not associated with an increase in morbidity or mortality. The lower survival observed with pharmacological treatment in the unadjusted analyses was not maintained after adjustment.

Discussion

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Cite This Study

Torres-Muñoz et al. (2026) conducted a cohort in Hemodynamically significant patent ductus arteriosus (PDA) in preterm infants (n=156). Pharmacological treatment (intravenous ibuprofen or paracetamol) vs. Expectant management (no pharmacological treatment for PDA) was evaluated on Mortality before hospital discharge (HR 2.25, 95% CI 0.86-5.88, p=0.09). Pharmacological treatment of patent ductus arteriosus was not independently associated with in-hospital mortality compared to expectant management after multivariable adjustment (HR 2.25, p=0.09).

synapsesocial.com/papers/6aee6b6871a75948062208d2 https://doi.org/10.3389/fped.2026.1952588

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Mortality and clinical outcomes in preterm infants with patent ductus arteriosus according to pharmacological treatment or expectant management: a retrospective cohort study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Mortality and clinical outcomes in preterm infants with patent ductus arteriosus according to pharmacological treatment or expectant management: a retrospective cohort study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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