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  1. Article ; Online: Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

    Gupta, Samir / Subhedar, Nimish V / Bell, Jennifer L / Field, David / Bowler, Ursula / Hutchison, Elizabeth / Johnson, Sam / Kelsall, Wilf / Pepperell, Justine / Roberts, Tracy / Sinha, Sunil / Stanbury, Kayleigh / Wyllie, Jonathan / Hardy, Pollyanna / Juszczak, Edmund

    The New England journal of medicine

    2024  Volume 390, Issue 4, Page(s) 314–325

    Abstract: Background: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.: Methods: We ... ...

    Abstract Background: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.
    Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.5 mm with pulsatile flow) in extremely preterm infants (born between 23 weeks 0 days' and 28 weeks 6 days' gestation). The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age.
    Results: A total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses. A primary-outcome event occurred in 220 of 318 infants (69.2%) in the ibuprofen group and 202 of 318 infants (63.5%) in the placebo group (adjusted risk ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 176 of 274 (64.2%) in the ibuprofen group and 169 of 285 (59.3%) in the placebo group (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.
    Conclusions: The risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977.).
    MeSH term(s) Humans ; Infant, Newborn ; Anti-Inflammatory Agents, Non-Steroidal/administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Bronchopulmonary Dysplasia/etiology ; Bronchopulmonary Dysplasia/mortality ; Ductus Arteriosus, Patent/complications ; Ductus Arteriosus, Patent/drug therapy ; Ductus Arteriosus, Patent/mortality ; Ibuprofen/administration & dosage ; Ibuprofen/adverse effects ; Ibuprofen/therapeutic use ; Infant, Extremely Premature ; Cyclooxygenase Inhibitors/administration & dosage ; Cyclooxygenase Inhibitors/adverse effects ; Cyclooxygenase Inhibitors/therapeutic use ; Double-Blind Method ; Time Factors ; Treatment Outcome
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Ibuprofen (WK2XYI10QM) ; Cyclooxygenase Inhibitors
    Language English
    Publishing date 2024-01-24
    Publishing country United States
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa2305582
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Correction to: Study protocol: baby-OSCAR Trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

    Gupta, Samir / Juszczak, Edmund / Hardy, Pollyanna / Subhedar, Nimish / Wyllie, Jonathan / Kelsall, Wilf / Sinha, Sunil / Johnson, Sam / Roberts, Tracy / Hutchison, Elisabeth / Pepperell, Justine / Linsell, Louise / Bell, Jennifer L / Stanbury, Kayleigh / Laube, Marketa / Edwards, Clare / Field, David

    BMC pediatrics

    2021  Volume 21, Issue 1, Page(s) 326

    Language English
    Publishing date 2021-07-27
    Publishing country England
    Document type Published Erratum
    ZDB-ID 2041342-7
    ISSN 1471-2431 ; 1471-2431
    ISSN (online) 1471-2431
    ISSN 1471-2431
    DOI 10.1186/s12887-021-02785-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.

    Gupta, Samir / Juszczak, Edmund / Hardy, Pollyanna / Subhedar, Nimish / Wyllie, Jonathan / Kelsall, Wilf / Sinha, Sunil / Johnson, Sam / Roberts, Tracy / Hutchison, Elisabeth / Pepperell, Justine / Linsell, Louise / Bell, Jennifer L / Stanbury, Kayleigh / Laube, Marketa / Edwards, Clare / Field, David

    BMC pediatrics

    2021  Volume 21, Issue 1, Page(s) 100

    Abstract: Background: The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks' gestation are born in the UK ... ...

    Abstract Background: The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks' gestation are born in the UK every year. In 40% of cases the PDA will fail to close spontaneously, even by 4 months of age. Untreated PDA can be associated with several serious and life-threatening short and long-term complications. Reliable data to support clinical decisions about PDA treatment are needed to prevent serious complications in high risk babies, while minimising undue exposure of infants. With the availability of routine bedside echocardiography, babies with a large PDA can be diagnosed before they become symptomatic.
    Methods: This is a multicentre, masked, randomised, placebo-controlled parallel group trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies (23
    Discussion: Prophylactic pharmacological treatment of all preterm babies unnecessarily exposes them to potentially serious side effects of drug treatment, when their PDA may have closed spontaneously. However, delaying treatment until babies become symptomatic could result in loss of treatment benefit as irreversible damage may have already been done. Targeted, early pharmacological treatment of PDA in asymptomatic babies has the potential to overcome the disadvantages of both prophylactic (overtreatment) and symptomatic approaches (potentially too late). This could result in improvements in the clinically important short-term clinical (mortality and moderate or severe BPD at 36 weeks' postmenstrual age) and long-term health outcomes (moderate or severe neurodevelopment disability and respiratory morbidity) measured at 2 years corrected age.
    Trial registration: ISRCTN84264977 . Date assigned: 15/09/2010.
    MeSH term(s) Bronchopulmonary Dysplasia/prevention & control ; Ductus Arteriosus, Patent/diagnostic imaging ; Ductus Arteriosus, Patent/drug therapy ; Humans ; Ibuprofen/therapeutic use ; Infant ; Infant, Low Birth Weight ; Infant, Newborn ; Infant, Premature, Diseases/drug therapy ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic
    Chemical Substances Ibuprofen (WK2XYI10QM)
    Language English
    Publishing date 2021-02-26
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041342-7
    ISSN 1471-2431 ; 1471-2431
    ISSN (online) 1471-2431
    ISSN 1471-2431
    DOI 10.1186/s12887-021-02558-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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