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| Neonatal Med > Volume 33(1); 2026 > Article |
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Conflicts of interest
Byong Sop Lee is an editor-in-chief of the journal, but he was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.
Author contributions
Conception or design: S.M.L., B.S.L.
Acquisition, analysis, or interpretation of data: M.Y.H.
Drafting the work or revising: B.S.L., M.Y.H., H.H.K., T.H.C., S.H.K., E.K.C., J.S.H., Y.M.Y., K.H.C., B.K.L., E.S.S., S.I.S., Y.S.C.
Final approval of the manuscript: All authors read and approved the final manuscript.
Acknowledgments
The Task Force on patent ductus arteriosus (PDA) in Preterm Infants comprised members of the Scientific Committee, Editorial Committee, and Survey and Statistics Committee of the Korean Society of Neonatology, and the Insurance Affairs Committee of the Korean Society of Pediatric Cardiology.
The recommendations in this statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate.
| Published year | Reference/Study name | Population (including enrolled no. of patients) | Intervention | Comparison | Primary outcome | Key results |
|---|---|---|---|---|---|---|
| 2019 | Clyman et al. [51]/PDA-TOLERATE | Preterm infants <28 weeks’ gestation with moderate-to-large PDA at 6–14 days of age; n=202 | Early routine pharmacologic PDA treatment with indomethacin, ibuprofen, or acetaminophen according to site practice | Conservative treatment, with rescue therapy only when prespecified cardiopulmonary criteria were met | PDA ligation or persistent PDA at discharge | Early routine treatment did not significantly reduce PDA ligation or persistent PDA at discharge and did not clearly improve major neonatal outcomes. |
| 2020 | Sung et al. [21] | Preterm infants 23–30 weeks’ gestation with hemodynamically significant PDA diagnosed between postnatal days 6 and 14; n=142 | Nonintervention/placebo | Oral ibuprofen | BPD or death | Nonintervention was noninferior to oral ibuprofen for BPD or death. Ibuprofen increased ductal closure, but this did not translate into improved short-term clinical outcomes. |
| 2021 | Roze et al. [50]/TRIOCAPI | Extremely preterm infants with large PDA detected by early echocardiography; n= 228 randomized | Early echocardiography-targeted ibuprofen treatment | Placebo/no early pharmacologic closure | Survival without cerebral palsy at 2 years | Early targeted ibuprofen reduced early PDA persistence but did not improve survival without cerebral palsy at 2 years. |
| 2023 | Hundscheid et al. [14]/BeNeDuctus | Extremely preterm infants with echocardiographically confirmed PDA; n=273 | Expectant management | Early ibuprofen treatment | Composite of NEC, moderate-to-severe BPD, or death at 36 weeks’ postmenstrual age | Expectant management was noninferior to early ibuprofen for the composite outcome. The primary outcome was numerically less frequent in the expectant-management group. |
| 2024 | Gupta et al. [19]/Baby-OSCAR | Extremely preterm infants 23+0 to 28+6 weeks’ gestation with large PDA within 72 hours after birth; n= 653 | Early selective intravenous ibuprofen | Placebo | Death or moderate/severe BPD at 36 weeks’ postmenstrual age | Ibuprofen reduced PDA persistence or size but did not reduce death or moderate/severe BPD. |
| 2026 | Laughon et al. [20]/NICHD Neonatal Research Network PDA Trial | Extremely preterm infants 22–28 weeks’ gestation with protocol-defined PDA between 48 hours and 21 days of age; n=482 randomized | Expectant management | Active pharmacologic PDA closure with acetaminophen, ibuprofen, or indomethacin | Death or BPD at 36 weeks’ postmenstrual age | Death or BPD did not differ between groups. Death before 36 weeks’ postmenstrual age was lower in the expectant-management group than in the active-treatment group. |
| 2026 | Roze et al. [52]/TREOCAPA | Preterm infants 23+0 to 28+6 weeks’ GA enrolled within 12 hours after birth; 43 NICUs in 14 European countries; n= 778 | Prophylactic IV acetaminophen for 5 days | Placebo | Survival without severe neonatal morbidity at 36 weeks’ PMA | No improvement in survival without severe morbidity; day-7 ductal closure increased, but cholestasis was more frequent. |
| Clinical situation/strategy | AAP recommendation summary [17] | Level of evidence |
|---|---|---|
| Prophylactic medical treatment | Not recommended | 1A |
| Early fluid restriction and diuretics use | Early fluid restriction may reduce PDA incidence (from old data) | 1A/2B/2B |
| No evidence to support fluid restriction after diagnosis of hsPDA | ||
| Furosemide may be useful as an adjunct | ||
| Very early or early routine closure (<72 hours or <7–14 days) | Not recommended | 1A |
| Conservative management in early period | May avoid unnecessary medication or procedural exposure and allow spontaneous closure | NA |
| hsPDA beyond 2 weeks of age | Insufficient data for recommendations | NA |
| Pharmacologic treatment beyond 2 weeks | May be considered. | 5 |
| Persistent hsPDA beyond 2 weeks after up to 2 treatment courses | Transcatheter closure or surgical ligation may be considered | 4 |

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