Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments
Condition: Extreme Prematurity; Covid19
MeSH terms: COVID-19; Premature Birth
Study type: Observational

Summary: 
      This is a retrospective, observational study based on the consortium of the SafeBoosC-III
      randomised clinical trial. This study will evaluate if the number of admitted extremely
      preterm infants has decreased in the SafeBoosC-III departments during the global lockdown,
      and whether there is an association between the level of lockdown restrictions and change in
      the number of ELGAN admissions.
    

Detailed description: 
      On the 11th of March 2020, COVID-19 was declared a pandemic by the World Health Organisation,
      which led to an almost worldwide lockdown (1). During the lockdown, reductions in preterm
      birth rates and very low birth weight infants have been reported in both Danish and Irish
      studies. Within the SafeBoosC-III investigator group, several neonatologists concurrently
      observed that the number of extremely low gestational age neonates (ELGAN) (gestational age
      below 28 weeks) admitted to their respective departments, had declined during the pandemic,
      while others observed no difference in the number of admitted ELGAN (oral communication).
      Furthermore, despite a 60% increase in the number of hospitals open for randomisation in the
      SafeBoosC-III trial from January to May, the randomisation rate has not increased as
      expected. Investigators are therefore curious to evaluate if the number of admitted extremely
      preterm infants has decreased in the SafeBoosC-III departments during the global lockdown,
      and whether there is an association between the level of lockdown restrictions and change in
      the number of ELGAN admissions. Investigators hope that this study will contribute further to
      the knowledge of the COVID-19 pandemics' effect on ELGAN birth as well as its effect on
      international randomised clinical trials.

      This is a retrospective, observational study based on the consortium of the SafeBoosC-III
      randomised clinical trial. The SafeBoosC-III trial investigates the benefit and harms of
      treatment guided by cerebral near-infrared spectroscopy monitoring compared with treatment
      and monitoring as usual in extremely preterm infants. All 79 neonatal intensive care units
      (NICU) that are active in the consortium will be invited to participate in this study.
      Primary investigators will be contacted and asked to provide the number of extremely low
      gestational age neonates (ELGAN) admitted to their NICU within the most rigorous three months
      of the COVID-19 pandemic as well as the number of ELGAN admitted within the same period in
      2019. The most rigorous three months of the COVID-19 pandemic will be a subjective definition
      by the local investigator, based on when the lockdown restrictions were strictest.
      Investigators will be asked to clarify how and where the information has been obtained from.
      Furthermore, investigators will be asked to classify the level of restrictions imposed upon
      the public, during the lockdown period, in a Likert scale format from 1-5. Additionally,
      investigators will be asked to categorize the impact of the COVID-19 lockdown on the everyday
      life of a pregnant woman.

      The number of ELGAN admissions during the three peak months in total, during the same months
      in 2019, within each region and within each level of lockdown restriction, will be reported
      as numbers. The primary outcome and the secondary outcome regarding the difference in the
      number of ELGAN admissions between years and regions will be analysed by using Fisher's Exact
      test for 1x2 tables. To analyse the correlation between the level of lockdown restrictions
      and the change in number of ELGAN admissions, investigators will use simple linear
      regression. The exploratory outcome investigating if lockdown restrictions could lead to
      non-admittance of ELGAN will not undergo statistical analysis but will be reported and
      discussed. For the primary outcome, an alfa level of 5% is chosen as a threshold for
      significance. To correct for multiple testing in the secondary outcomes, investigators have
      chosen an alfa level of 1%

      In a previous funding application for the SafeBoosC-III trial, investigators estimated that
      the 93 departments taking part in the application, had a total of 3000 ELGAN admissions per
      year. Therefore, investigators expect participating departments on average to have had
      approximately 30 admissions in 2019, i.e. approximately seven admissions in a three months
      period. Therefore, if half of the NICUs (i.e. 40 departments) participate, investigators
      would expect a total of 280 EP infant admissions within the 40 departments in 2019. Thus, a
      16.5% change in the primary outcome is needed to show a statistical significance at a 5% alfa
      level.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Extremely premature infants (GA<28)
      
Keywords: extreme prematurity; safeboosc; RCT; COVID-19