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

October 5, 2020 updated by: Gorm Greisen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

885

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Neonatalklinikken, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Extremely premature infants (GA<28)

Description

Inclusion Criteria:

  • Extremely low gestational age neonates admitted to participating NICUs

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Gorm Greisen, MD, Prof, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2020

Primary Completion (Actual)

September 13, 2020

Study Completion (Actual)

September 13, 2020

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SafeBoosC COVID-19 ELGAN study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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