Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study)
Introduction Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwa...
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BMJ Publishing Group
2022-07-01
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| author | Anton H van Kaam Wes Onland Irwin K M Reiss Peter H Dijk Arend F Bos Eleni-Rosalina Andrinopoulou E Villamor LGM van Rooij M de Jong JS von Lindern Lucas Goossens Stephanie Balink Elianne J L E Vrijlandt Anthon R Hulsmann Debbie H Nuytemans Arwen J Sprij André A Kroon Marielle Pijnenburg MGA Baartmans GJ Blok WP de Boode HD Buiter CE Counsilman CA Dalen Meurs ACM Dassel AM de Grauw MEN van den Heuvel JLAM van Hillegersberg JCR van Hoften JHL van Hoorn CH ten Hove A Kamerbeek AAMW van Kempen LH van der Meer RMJ Moonen EEM Mulder HJ Niemarkt MAG van Scherpenzeel-de Vries IAM Schiering RNGB Tan |
| author_facet | Anton H van Kaam Wes Onland Irwin K M Reiss Peter H Dijk Arend F Bos Eleni-Rosalina Andrinopoulou E Villamor LGM van Rooij M de Jong JS von Lindern Lucas Goossens Stephanie Balink Elianne J L E Vrijlandt Anthon R Hulsmann Debbie H Nuytemans Arwen J Sprij André A Kroon Marielle Pijnenburg MGA Baartmans GJ Blok WP de Boode HD Buiter CE Counsilman CA Dalen Meurs ACM Dassel AM de Grauw MEN van den Heuvel JLAM van Hillegersberg JCR van Hoften JHL van Hoorn CH ten Hove A Kamerbeek AAMW van Kempen LH van der Meer RMJ Moonen EEM Mulder HJ Niemarkt MAG van Scherpenzeel-de Vries IAM Schiering RNGB Tan |
| author_sort | Anton H van Kaam |
| collection | DOAJ |
| description | Introduction Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwards. The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD.Methods and analysis This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. Infants will be randomised to either a lower oxygen saturation limit of 95% or to a lower limit of 90%; supplemental oxygen and/or respiratory support will be weaned based on the assigned lower oxygen saturation limit. Adherence to the oxygen saturation limit will be assessed by extracting oxygen saturation profiles from pulse oximeters regularly, until respiratory support is stopped. The primary outcome is the weight SD score at 6 months of corrected age. Secondary outcomes include anthropometrics collected at 6 and 12 months of corrected age, rehospitalisations, respiratory complaints, infant stress, parental quality of life and cost-effectiveness.Ethics and dissemination Ethical approval for the trial was obtained from the Medical Ethics Review Committee of the Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2018–1515). Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants.Trial registration number NL7149/NTR7347. |
| format | Article |
| id | doaj-art-9c04d4fed3754a7abd7a45fc38904e55 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-9c04d4fed3754a7abd7a45fc38904e552025-01-31T13:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-060986Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study)Anton H van Kaam0Wes Onland1Irwin K M Reiss2Peter H Dijk3Arend F Bos4Eleni-Rosalina Andrinopoulou5E VillamorLGM van RooijM de JongJS von LindernLucas Goossens6Stephanie Balink7Elianne J L E Vrijlandt8Anthon R Hulsmann9Debbie H Nuytemans10Arwen J Sprij11André A Kroon12Marielle Pijnenburg13MGA BaartmansGJ BlokWP de BoodeHD BuiterCE CounsilmanCA Dalen MeursACM DasselAM de GrauwMEN van den HeuvelJLAM van HillegersbergJCR van HoftenJHL van HoornCH ten HoveA KamerbeekAAMW van KempenLH van der MeerRMJ MoonenEEM MulderHJ NiemarktMAG van Scherpenzeel-de VriesIAM SchieringRNGB Tan3 Amsterdam University Medical Centers, Amsterdam, The NetherlandsAmsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDivision of Neonatology, Department of Paediatrics, Erasmus MC University Medical Center, Rotterdam, The NetherlandsDepartment of Paediatrics, Division of Neonatology, UMCG, Groningen, The NetherlandsDepartment of Paediatrics, Division of Neonatology, UMCG, Groningen, The Netherlands15 Department of Biostatistics, Department of Epidemiology, Erasmus Medical Center, Rotterdam, The NetherlandsErasmus School of Health Policy and Management, Erasmus Universiteit Rotterdam, Rotterdam, The NetherlandsDepartment of Paediatrics/Paediatric Respiratory Medicine, Erasmus MC Sophia Children Hospital, Rotterdam, The NetherlandsDepartment of Paediatrics, Division of Paediatric Pulmonology and Allergology, UMCG, Groningen, The NetherlandsDepartment of Paediatrics, Amphia Hospital, Breda, The NetherlandsDepartment of Paediatrics, Division of Neonatology, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDepartment of Paediatrics, Haga Hospital, Den Haag, The NetherlandsDepartment of Paediatrics, Division of Neonatology, Erasmus MC Sophia Children Hospital, Rotterdam, The NetherlandsDepartment of Paediatrics/Paediatric Respiratory Medicine, Erasmus MC Sophia Children Hospital, Rotterdam, The NetherlandsIntroduction Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwards. The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD.Methods and analysis This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. Infants will be randomised to either a lower oxygen saturation limit of 95% or to a lower limit of 90%; supplemental oxygen and/or respiratory support will be weaned based on the assigned lower oxygen saturation limit. Adherence to the oxygen saturation limit will be assessed by extracting oxygen saturation profiles from pulse oximeters regularly, until respiratory support is stopped. The primary outcome is the weight SD score at 6 months of corrected age. Secondary outcomes include anthropometrics collected at 6 and 12 months of corrected age, rehospitalisations, respiratory complaints, infant stress, parental quality of life and cost-effectiveness.Ethics and dissemination Ethical approval for the trial was obtained from the Medical Ethics Review Committee of the Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2018–1515). Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants.Trial registration number NL7149/NTR7347.https://bmjopen.bmj.com/content/12/7/e060986.full |
| spellingShingle | Anton H van Kaam Wes Onland Irwin K M Reiss Peter H Dijk Arend F Bos Eleni-Rosalina Andrinopoulou E Villamor LGM van Rooij M de Jong JS von Lindern Lucas Goossens Stephanie Balink Elianne J L E Vrijlandt Anthon R Hulsmann Debbie H Nuytemans Arwen J Sprij André A Kroon Marielle Pijnenburg MGA Baartmans GJ Blok WP de Boode HD Buiter CE Counsilman CA Dalen Meurs ACM Dassel AM de Grauw MEN van den Heuvel JLAM van Hillegersberg JCR van Hoften JHL van Hoorn CH ten Hove A Kamerbeek AAMW van Kempen LH van der Meer RMJ Moonen EEM Mulder HJ Niemarkt MAG van Scherpenzeel-de Vries IAM Schiering RNGB Tan Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) BMJ Open |
| title | Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) |
| title_full | Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) |
| title_fullStr | Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) |
| title_full_unstemmed | Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) |
| title_short | Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study) |
| title_sort | supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period study protocol for a randomised controlled trial sos bpd study |
| url | https://bmjopen.bmj.com/content/12/7/e060986.full |
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