TY - JOUR
T1 - Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period
T2 - study protocol for a randomised controlled trial (SOS BPD study)
AU - Balink, Stephanie
AU - Onland, Wes
AU - Vrijlandt, Elianne J. L. E.
AU - Andrinopoulou, Eleni-Rosalina
AU - Bos, Arend F.
AU - Dijk, Peter H.
AU - Goossens, Lucas
AU - Hulsmann, Anthon R.
AU - Nuytemans, Debbie H.
AU - Reiss, Irwin K. M.
AU - SOS BPD study group
AU - Sprij, Arwen J.
AU - Kroon, André A.
AU - van Kaam, Anton H.
AU - Pijnenburg, Marielle
N1 - Funding Information: This work was supported by the Lung Foundation Netherlands under grant number 4.1.17.162 and by Netherlands Organisation for Health Research and Development (ZonMW)—Efficiency Studies Programme under grant number 843 002 827. Publisher Copyright: © Author(s) (or their employer(s)) 2022.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85134426241&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-060986
DO - https://doi.org/10.1136/bmjopen-2022-060986
M3 - Article
C2 - 35803625
SN - 2044-6055
VL - 12
SP - e060986
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e060986
ER -