Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context
Summary: Background: Children born extremely preterm are at increased risk of developmental problems and respiratory morbidity due to patent ductus arteriosus (PDA). The objective of this study was to evaluate whether early treatment of a PDA ≥1.5 mm with ibuprofen improved neurodevelopmental and r...
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Elsevier
2025-09-01
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537025003566 |
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| author | Samir Gupta Heather O'Connor Edmund Juszczak Nimish V. Subhedar Ursula Bowler Charlotte Clarke David Field Elizabeth Hutchison Wilf Kelsall Justine Pepperell Tracy Roberts Sunil Sinha Kayleigh Stanbury Jonathan Wyllie Pollyanna Hardy Samantha Johnson |
| author_facet | Samir Gupta Heather O'Connor Edmund Juszczak Nimish V. Subhedar Ursula Bowler Charlotte Clarke David Field Elizabeth Hutchison Wilf Kelsall Justine Pepperell Tracy Roberts Sunil Sinha Kayleigh Stanbury Jonathan Wyllie Pollyanna Hardy Samantha Johnson |
| author_sort | Samir Gupta |
| collection | DOAJ |
| description | Summary: Background: Children born extremely preterm are at increased risk of developmental problems and respiratory morbidity due to patent ductus arteriosus (PDA). The objective of this study was to evaluate whether early treatment of a PDA ≥1.5 mm with ibuprofen improved neurodevelopmental and respiratory outcomes at 24 months of age, corrected for prematurity. Methods: Baby-OSCAR was a UK multi-center placebo-controlled masked randomized clinical trial in infants born 23+0–28+6 weeks' gestation. The main long-term outcome was survival without moderate or severe neurodevelopmental impairment at 24 months’ corrected age, assessed using parent report primarily or classified by blinded end-point review committee where parent-reported data were not available. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. (ISRCTN Registry number ISRCTN84264977). Findings: From July 2015 through December 2020, 653 infants underwent randomization. At 24 months’ corrected age, outcome data were available for 537 children: 263 in the ibuprofen group and 274 in the placebo group. Survival without moderate to severe neurodevelopmental impairment in the ibuprofen and placebo groups was 131/248 (53.0%) and 134/259 (51.9%) respectively; adjusted risk ratio 1.01 (95% confidence interval [CI] 0.86–1.18); p = 0.901. Survival without respiratory morbidity was 66/220 (30%) and 74/225 (32.9%) respectively; adjusted risk ratio 0.89 (95% CI 0.68–1.18). Median duration of oxygen supplementation from randomization was 76.0 and 78.0 days, respectively; adjusted median difference −1.5 (−13.8 to 10.9). Interpretation: We found no evidence of an improvement in neurodevelopmental and respiratory outcomes at 24 months’ corrected age, after selective early treatment of a PDA ≥1.5 mm with ibuprofen in children born extremely preterm. Funding: This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (11/92/15). |
| format | Article |
| id | doaj-art-51f47bb7b18a4c298bd41316525131a2 |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
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| series | EClinicalMedicine |
| spelling | doaj-art-51f47bb7b18a4c298bd41316525131a22025-08-22T04:57:13ZengElsevierEClinicalMedicine2589-53702025-09-018710342410.1016/j.eclinm.2025.103424Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in contextSamir Gupta0Heather O'Connor1Edmund Juszczak2Nimish V. Subhedar3Ursula Bowler4Charlotte Clarke5David Field6Elizabeth Hutchison7Wilf Kelsall8Justine Pepperell9Tracy Roberts10Sunil Sinha11Kayleigh Stanbury12Jonathan Wyllie13Pollyanna Hardy14Samantha Johnson15Division of Neonatology, Sidra Medicine, Doha, Qatar; Department of Engineering, Durham University, UK; Corresponding author. Division Chief of Neonatology, Dept. of Pediatrics, Sidra Medicine, Al Luqta Street, Education City North Campus, Qatar Foundation, PO Box 26999, Doha, Qatar.National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKNottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UKLiverpool Women's NHS Foundation Trust, Liverpool, UKNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKNuffield Department of Population Health, University of Oxford, UKDepartment of Population Health Sciences, University of Leicester, UKNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKNICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge, UKNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKSouth Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UKNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKSouth Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UKNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, UKDepartment of Population Health Sciences, University of Leicester, UKSummary: Background: Children born extremely preterm are at increased risk of developmental problems and respiratory morbidity due to patent ductus arteriosus (PDA). The objective of this study was to evaluate whether early treatment of a PDA ≥1.5 mm with ibuprofen improved neurodevelopmental and respiratory outcomes at 24 months of age, corrected for prematurity. Methods: Baby-OSCAR was a UK multi-center placebo-controlled masked randomized clinical trial in infants born 23+0–28+6 weeks' gestation. The main long-term outcome was survival without moderate or severe neurodevelopmental impairment at 24 months’ corrected age, assessed using parent report primarily or classified by blinded end-point review committee where parent-reported data were not available. Other secondary outcomes included survival without respiratory morbidity and duration of oxygen supplementation. (ISRCTN Registry number ISRCTN84264977). Findings: From July 2015 through December 2020, 653 infants underwent randomization. At 24 months’ corrected age, outcome data were available for 537 children: 263 in the ibuprofen group and 274 in the placebo group. Survival without moderate to severe neurodevelopmental impairment in the ibuprofen and placebo groups was 131/248 (53.0%) and 134/259 (51.9%) respectively; adjusted risk ratio 1.01 (95% confidence interval [CI] 0.86–1.18); p = 0.901. Survival without respiratory morbidity was 66/220 (30%) and 74/225 (32.9%) respectively; adjusted risk ratio 0.89 (95% CI 0.68–1.18). Median duration of oxygen supplementation from randomization was 76.0 and 78.0 days, respectively; adjusted median difference −1.5 (−13.8 to 10.9). Interpretation: We found no evidence of an improvement in neurodevelopmental and respiratory outcomes at 24 months’ corrected age, after selective early treatment of a PDA ≥1.5 mm with ibuprofen in children born extremely preterm. Funding: This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (11/92/15).http://www.sciencedirect.com/science/article/pii/S2589537025003566Patent ductus arteriosusPrematureNeurodevelopmental outcomesRespiratory outcomeDeath |
| spellingShingle | Samir Gupta Heather O'Connor Edmund Juszczak Nimish V. Subhedar Ursula Bowler Charlotte Clarke David Field Elizabeth Hutchison Wilf Kelsall Justine Pepperell Tracy Roberts Sunil Sinha Kayleigh Stanbury Jonathan Wyllie Pollyanna Hardy Samantha Johnson Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context EClinicalMedicine Patent ductus arteriosus Premature Neurodevelopmental outcomes Respiratory outcome Death |
| title | Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context |
| title_full | Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context |
| title_fullStr | Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context |
| title_full_unstemmed | Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context |
| title_short | Two-year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies: follow-up of Baby-OSCAR–a randomised controlled trialResearch in context |
| title_sort | two year outcomes after selective early treatment of patent ductus arteriosus with ibuprofen in preterm babies follow up of baby oscar a randomised controlled trialresearch in context |
| topic | Patent ductus arteriosus Premature Neurodevelopmental outcomes Respiratory outcome Death |
| url | http://www.sciencedirect.com/science/article/pii/S2589537025003566 |
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