Evidence map›Paper›PMID 29320647›Full record

Trial reportThe New England journal of medicine2018

Long-Term Effects of Inhaled Budesonide for Bronchopulmonary Dysplasia.

Dirk Bassler, Eric S Shinwell, Mikko Hallman, Pierre-Henri Jarreau, Richard Plavka, Virgilio Carnielli, Christoph Meisner, Corinna Engel, Alexander Koch, Karen Kreutzer and 5 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01035190 (Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia), which is not on this map. Cited by 58 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 7 pooled it
13.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01035190 phase3completednot on this map

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

TypeinterventionalSponsorUniversity Children's Hospital TuebingenRan2010 to 2016Enrolled863ConditionsBronchopulmonary DysplasiaArmsBudesonide
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 7 syntheses or guidelines pooled it, 139 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Trial
  9. Review
  10. Article
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  13. Prescribing practices of inhaled corticosteroids for premature infants in the neonatal intensive care unit.Journal of perinatology : official journal of the California Perinatal Association · 2024
    Article
  14. Review
  15. Article
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  20. Preterm lung and brain responses to mechanical ventilation and corticosteroids.Journal of perinatology : official journal of the California Perinatal Association · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 13 countries.

Dirk BasslerFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Eric S ShinwellFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Mikko HallmanFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Pierre-Henri JarreauFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Richard PlavkaFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Virgilio CarnielliFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Christoph MeisnerFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Corinna EngelFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Alexander KochFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Karen KreutzerFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Johannes N van den AnkerFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Matthias SchwabFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Henry L HallidayFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Christian F PoetsFrom the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel (J.N.A.) - both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland (M.H.); Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire Risques et Grossesse, Université Paris Descartes, Hôpital Cochin, Service de Médecine et Réanimation Néonatales de Port-Royal, Paris (P.-H.J.); Charles University, General Faculty Hospital and 1st Faculty of Medicine in Prague, Prague, Czech Republic (R.P.); Polytechnical University of Marche, Salesi Children's Hospital, Ancona, Italy (V.C.); Institute for Clinical Epidemiology and Applied Biometry (C.M.), University Children's Hospital Tübingen, Center for Pediatric Clinical Studies (C.E.), Department of Neonatology, University Children's Hospital (A.K., K.K., C.F.P.), and Department of Clinical Pharmacology and Department of Pharmacy and Biochemistry, University Hospital and University of Tübingen (M.S.), Tübingen, and Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart (M.S.) - all in Germany; Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands (J.N.A.); the Division of Clinical Pharmacology, Children's National Health System, Washington, DC (J.N.A.); and the Department of Child Health at Queen's University Belfast, Institute of Clinical Science, Belfast, United Kingdom (H.L.H.).
Neonatal European Study of Inhaled Steroids Trial Group
Assistance Publique – Hôpitaux de Paris · FRBar-Ilan University · ILCharles University · CZChildren's Clinical University Hospital · LVDr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology · DEErasmus MC - Sophia Children’s Hospital · NLMarche Polytechnic University · ITOulu University Hospital · FIQueen's University Belfast · GBTemple Street Children's University Hospital · IEUniversity Children's Hospital Tübingen · DEUniversity of Zurich · CHUniwersytecki Szpital Dziecięcy · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe long-term effects on neurodevelopment of the use of inhaled glucocorticoids in extremely preterm infants for the prevention or treatment of bronchopulmonary dysplasia are uncertain.

methodsWe randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to receive early (within 24 hours after birth) inhaled budesonide or placebo. The prespecified secondary long-term outcome was neurodevelopmental disability among survivors, defined as a composite of cerebral palsy, cognitive delay (a Mental Development Index score of <85 [1 SD below the mean of 100] on the Bayley Scales of Infant Development, Second Edition, with higher scores on the scale indicating better performance), deafness, or blindness at a corrected age of 18 to 22 months.

resultsAdequate data on the prespecified composite long-term outcome were available for 629 infants. Of these infants, 148 (48.1%) of 308 infants assigned to budesonide had neurodevelopmental disability, as compared with 165 (51.4%) of 321 infants assigned to placebo (relative risk, adjusted for gestational age, 0.93; 95% confidence interval [CI], 0.80 to 1.09; P=0.40). There was no significant difference in any of the individual components of the prespecified outcome. There were more deaths in the budesonide group than in the placebo group (82 [19.9%] of 413 infants vs. 58 [14.5%] of 400 infants for whom vital status was available; relative risk, 1.37; 95% CI, 1.01 to 1.86; P=0.04).

conclusionsAmong surviving extremely preterm infants, the rate of neurodevelopmental disability at 2 years did not differ significantly between infants who received early inhaled budesonide for the prevention of bronchopulmonary dysplasia and those who received placebo, but the mortality rate was higher among those who received budesonide. (Funded by the European Union and Chiesi Farmaceutici; ClinicalTrials.gov number, NCT01035190 .).

Indexed as

Infant, Extremely PrematureAdministration, InhalationBlindnessBronchopulmonary DysplasiaBudesonideCerebral PalsyCognition DisordersDevelopmental DisabilitiesFemaleFollow-Up StudiesGestational AgeGlucocorticoidsHearing LossHumansInfant, NewbornInfant, Premature, DiseasesBudesonideGlucocorticoids

Identifiers

PMID29320647
OpenAlexW2784047332

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