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Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments

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ClinicalTrials.gov Identifier: NCT04527601
Recruitment Status : Completed
First Posted : August 26, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief 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.

Condition or disease
Extreme Prematurity Covid19

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.

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Study Type : Observational
Actual Enrollment : 885 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments
Actual Study Start Date : August 21, 2020
Actual Primary Completion Date : September 13, 2020
Actual Study Completion Date : September 13, 2020

Group/Cohort
ELGAN admissions during peak three months of COVID-19 pandemic
ELGAN admissions in the three corresponding months of 2019



Primary Outcome Measures :
  1. Number of ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 [ Time Frame: 3 months ]
    The primary outcome will be the difference in the total number of ELGAN admissions in SafeBoosC-III departments during the peak three months of the COVID-19 pandemic in 2020 compared to the same three months 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.


Secondary Outcome Measures :
  1. Regional difference in ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 [ Time Frame: 3 months ]

    The difference in the number of ELGAN admissions during the peak three months of the COVID-19 pandemic versus the same three months in 2019, within the following regions:

    North America: USA Northern Europe: Denmark, Norway Eastern Europe: Austria, Poland, Czech Republic, Ukraine, Turkey Western Europe: Germany, UK, Ireland, Switzerland, Belgium Southern Europe: Spain, Portugal, Italy, Greece Asia: India, China


  2. Correlation between the level of lockdown restrictions and number of ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Likelihood of restrictions leading to non-admittance of ELGAN [ Time Frame: 3 months ]
    For the purpose of an exploratory analysis, we will ask investigators to rate the likelihood that restrictions outside or inside health institutions in their country/region, have led to non-admittance of ELGAN. Causes could be intrauterine death, or no transfer from place of birth



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Extremely premature infants (GA<28)
Criteria

Inclusion Criteria:

  • Extremely low gestational age neonates admitted to participating NICUs

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527601


Locations
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Denmark
Neonatalklinikken, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Gorm Greisen, MD, Prof Rigshospitalet, Denmark
Additional Information:
Publications:
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Responsible Party: Gorm Greisen, MD, professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04527601    
Other Study ID Numbers: SafeBoosC COVID-19 ELGAN study
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
extreme prematurity
safeboosc
RCT
COVID-19
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications