Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

  1. Marie Isabel Rasmussen
  2. Mathias Lühr Hansen
  3. Gerhard Pichler
  4. Eugene Dempsey
  5. Adelina Pellicer
  6. Afif EL-Khuffash
  7. Shashidhar A
  8. Salvador Piris-Borregas
  9. Miguel Alsina
  10. Merih Cetinkaya
  11. Lina Chalak
  12. Hilal Özkan
  13. Mariana Baserga
  14. Jan Sirc
  15. Hans Fuchs
  16. Ebru Ergenekon
  17. Luis Arruza
  18. Amit Mathur
  19. Martin Stocker
  20. Olalla Otero Vaccarello
  21. Tomasz Szczapa
  22. Kosmas Sarafidis
  23. Barbara Królak-Olejnik
  24. Asli Memisoglu
  25. Hallvard Reigstad
  26. Elżbieta Rafińska-Ważny
  27. Eleftheria Hatzidaki
  28. Zhang Peng
  29. Despoina Gkentzi
  30. Renaud Viellevoye
  31. Julie De Buyst
  32. Emmanuele Mastretta
  33. Ping Wang
  34. Gitte Holst Hahn
  35. Lars Bender
  36. Luc Cornette
  37. Jakub Tkaczyk
  38. Ruth del Rio
  39. Monica Fumagalli
  40. Evangelia Papathoma
  41. Maria Wilinska
  42. Gunnar Naulaers
  43. Iwona Sadowska-Krawczenko
  44. Chantal Lecart
  45. María Luz Couce
  46. Siv Fredly
  47. Anne Marie Heuchan
  48. Tanja Karen
  49. Gorm Greisen

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Abstract

Objective: To evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019.

Design: This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated. Principal investigators were asked to report the following information: (1) Total number of EP infant admissions to their NICU in the 3 months where the lockdown restrictions were most rigorous during the first phase of the COVID-19 pandemic, (2) Similar EP infant admissions in the corresponding 3 months of 2019, (3) the level of local restrictions during the lockdown period, and (4) the local impact of the COVID-19 lockdown on the everyday life of a pregnant woman.

Results: The number of EP infant admissions during the first wave of the COVID-19 pandemic was 428 compared to 457 in the corresponding 3 months in 2019 (−6.6%, 95% CI −18.2 to +7.1%, p = 0.33). There were no statistically significant differences within individual geographic regions and no significant association between the level of lockdown restrictions and difference in the number of EP infant admissions. A post-hoc analysis based on data from the 46 NICUs found a decrease of 10.3%in the total number of NICU admissions ( n = 7,499 in 2020 vs. n = 8,362 in 2019).

Conclusion: This ad hoc study did not confirm previous reports of a major reduction in the number of extremely pretermbirths during the first phase of the COVID-19 pandemic.

Clinical Trial Registration: ClinicalTrial.gov , identifier: NCT04527601 (registered August 26, 2020), https://clinicaltrials.gov/ct2/show/NCT04527601 .

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  1. Version published to 10.3389/fped.2021.647880
  2. ScreenIT

    SciScore for 10.1101/2020.10.02.20204578: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: Predefined regions based on the active SafeBoosC-III NICUs can be found in table 1 Ethical considerations: The Danish National Committee on Health Research Ethics ruled that this study did not constitute a health research project, therefore permission to conduct this study was not necessary.
    IACUC: To our knowledge, two participating European NICUs consulted with their local ethical committee, regarding the need for approval, but this was not required either.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistics were conducted in IBM SPSS Statistics 25 (IBM, Armonk, NY, US).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This may pose as a limitation in regards to response bias. It is plausible, however, that most of these biases would have induced a false association between the change in numbers and the possible explaining factors. Many of the principal investigators participating in this study, are representing NICUs from the same countries (e.g. five NICUs from Belgium). It is plausible that some EP infants are transferred between hospitals within the same country, which potentially could lead to a false high number of total admissions, since the same EP infant would count as an admission in more than one hospital. Such an issue would cause a false high number of admissions and thereby, a false high power. For EP infants re-admissions are likely, due to e.g. respiratory, gastro-intestinal or sensory problems. If re-admissions are included in the counted infants, this could also cause a false high power, however if it is done consistently for both 2019 and 2020 numbers, it will unlikely bias results. The analysis of number of admissions within each geographical region revealed no statistically significant differences between the three months where the lockdown restrictions were most rigorous in 2020 compared to the corresponding months of 2019. The p-values were adjusted to correct for multiple testing in the secondary outcome analyses. Furthermore, the small number of admissions which each region increases the risk of type II errors (10). Thus, studies with a larger number of admissions w...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04527601CompletedExtremely Premature Births During the Peak of the COVID-19 P…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.10.02.20204578v1 on medRxiv