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Observational Study
. 2025 Apr:279:114456.
doi: 10.1016/j.jpeds.2024.114456. Epub 2024 Dec 26.

Changes in Patent Ductus Arteriosus Management and Outcomes in Infants Born at 26-28 Weeks' Gestation

Affiliations
Observational Study

Changes in Patent Ductus Arteriosus Management and Outcomes in Infants Born at 26-28 Weeks' Gestation

Dinushan C Kaluarachchi et al. J Pediatr. 2025 Apr.

Abstract

Objective: To investigate the association between the secular decrease in treatment of patent ductus arteriosus (PDA) and trends in neonatal mortality and morbidity in infants born at 26 0/7-28 6/7 weeks' gestation.

Study design: A retrospective cohort study including infants born between 2012 and 2021 in continually participating hospitals in the National Institute of Child Health and Human Development Neonatal Research Network. The primary composite outcome was defined as surgical necrotizing enterocolitis, grade 2-3 bronchopulmonary dysplasia (BPD), severe intraventricular hemorrhage, or death. Relationships of temporal trends in PDA treatment with the primary composite outcome and its components were analyzed using a multilevel model accounting for patient-level factors. A separate analysis assessed these relationships stratified by hospital changes in PDA treatment.

Results: The study included 7864 infants. There was a decrease in any PDA treatment from 21% to 16% (P < .01) and an increase in the primary composite outcome from 24% to 36% (P < .01). Change in the primary outcome was driven by increased grade 2-3 BPD (13%-26%, P < .01), with grade 2 BPD accounting for most of this increase (10%-22%, P < .01). Temporal decreases in PDA treatment were associated with increases in the primary outcome and grade 2-3 BPD after adjusting for patient-level factors (P < .01). However, stratified analyses showed that grade 2-3 BPD increased in all hospital groups, regardless of changes in PDA management.

Conclusions: From 2012 to 2021, temporal decreases in PDA treatment for infants 26-28 weeks were associated with an increase in grade 2-3 BPD. However, caution is warranted in determining causality. Reasons for increased grade 2-3 BPD during the past decade warrant investigation.

Trial registration: Generic Database: NCT00063063.

Keywords: bronchopulmonary dysplasia; outcomes; patent ductus arteriosus; preterm infant; secular trends.

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Conflict of interest statement

Declaration of Competing Interest The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (U10 HD27871, U10 HD53119, UG1 HD21364, UG1 HD21373, UG1 HD21385, UG1 HD27851, UG1 HD27853, UG1 HD27856, UG1 HD27880, UG1 HD27904, UG1 HD34216, UG1 HD36790, UG1 HD40492, UG1 HD40689, UG1 HD53089, UG1 HD53109, UG1 HD68244, UG1 HD68270, UG1 HD68278, UG1 HD68263, UG1 HD68284, UG1 HD87226, UG1 HD87229) and the National Center for Advancing Translational Sciences (NCATS) (UL1 TR6, UL1 TR41, UL1 TR42, UL1 TR77, UL1 TR93, UL1 TR442, UL1 TR454, UL1 TR1117) provided grant support through cooperative agreements for the Neonatal Research Network. NICHD staff provided input into the study design, conduct, analysis, and manuscript drafting; NCRR and NCATS cooperative agreements provided infrastructure support to the NRN. Although NICHD staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD, the National Institutes of Health, the Department of Health and Human Services, or the U.S. Government. Dr Kaluarachchi serves as a consultant for ONY Biotech Inc. Dr Backes has following disclosures—Abbott Laboratories: funding of ongoing multicenter trial, in partnership with National Institutes of Health, entitled PIVOTAL (NCT05547165). Abbott Laboratories has no part in the design or execution of PIVOTAL. Dr McNamara serves as a consultant for Abbott Laboratories and Aspect Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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