Related Experiment Video
Updated: Jan 9, 2026
Hemodynamic Precision in the Neonatal Intensive Care Unit using Targeted Neonatal Echocardiography
Published on: January 27, 2023
Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants: The PDA Randomized Clinical Trial
Matthew M Laughon1, Sonia M Thomas2, Kristi L Watterberg3
1Department of Pediatrics, University of North Carolina at Chapel Hill.
Insights
Expectant management of patent ductus arteriosus (PDA) in preterm infants did not increase death or bronchopulmonary dysplasia (BPD). This approach showed substantially higher survival rates compared to active treatment for PDA in extremely preterm infants.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Clinical Trials
Background:
- Management of patent ductus arteriosus (PDA) in preterm infants remains a significant clinical challenge.
- Existing treatment strategies for PDA carry potential risks and benefits that require careful consideration.
Purpose of the Study:
- To compare expectant management versus active treatment for protocol-defined PDA in preterm infants.
- To assess the impact of these management strategies on the incidence of death or bronchopulmonary dysplasia (BPD).
Main Methods:
- A randomized clinical trial involving 482 infants born between 22-28 weeks' gestation with a diagnosed PDA.
- Infants were randomized to either expectant management or active pharmacological treatment (acetaminophen, ibuprofen, or indomethacin).
- Primary outcome was death or BPD at 36 weeks' postmenstrual age.
Main Results:
- No significant difference in the combined outcome of death or BPD between expectant management (80.9%) and active treatment (79.6%).
- Expectant management group demonstrated significantly higher survival rates (95.9%) compared to the active treatment group (90.4%).
- Lower incidence of death due to infections was observed in the expectant management group.
Conclusions:
- Expectant management of PDA in extremely preterm infants is not associated with an increased risk of death or BPD.
- Expectant management appears to improve survival rates in this vulnerable population.
- These findings suggest a potential shift in the management paradigm for PDA in preterm neonates.
Importance:
The management of patent ductus arteriosus (PDA) in preterm infants is controversial.
Objective:
To determine whether expectant management compared with active treatment of a protocol-defined PDA in preterm infants decreases the incidence of death or bronchopulmonary dysplasia (BPD).
Design, Setting, And Participants:
A randomized clinical trial including infants born at 22 to 28 weeks' gestation and diagnosed with a protocol-defined PDA between the age of 48 hours and 21 days at screening. The trial was conducted from December 2018 to December 2024 at 33 hospitals within the National Institute of Child Health and Human Development Neonatal Research Network. The final date of follow-up was June 2025.
Interventions:
Infants with PDA were randomized to expectant management (n = 242) or active treatment (n = 240; acetaminophen, ibuprofen, or indomethacin) to close the PDA.
Main Outcomes And Measures:
The primary outcome was death or BPD at 36 weeks' postmenstrual age. The secondary outcomes included the components of the primary outcome and other morbidities of prematurity.
Results:
A total of 482 infants were randomized (median gestational age, 25 weeks [IQR, 24 to 27 weeks]; median birth weight, 760 g [IQR, 620 to 935 g]). The trial was stopped for futility and safety after the 50% interim analysis for the primary outcome due to higher survival in the expectant management group. The incidence of death or BPD was 80.9% (195/241) of infants in the expectant management group vs 79.6% (191/240) of infants in the active treatment group (adjusted risk difference, 1.2% [95% CI, -5.7% to 8.1%]; P = .73). The incidence of death before 36 weeks' postmenstrual age was 4.1% (10/241) of infants in the expectant management group vs 9.6% (23/240) of infants in the active treatment group (adjusted risk difference, -5.6% [95% CI, -10.1% to -1.2%]; P = .01). Infections resulting in death occurred in 0.8% (2/241) of infants in the expectant management group vs 3.8% (9/240) of infants in the active treatment group.
Conclusions And Relevance:
In extremely preterm infants with a protocol-defined PDA, death or BPD did not differ between the expectant management group and the active treatment group. Survival was substantially higher with expectant management.
Trial Registration:
ClinicalTrials.gov Identifier: NCT03456336.
Related Concept Videos
01:18Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
01:23Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
01:29Drug Dosing: Infants and Children