NCT04527601|Completed
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Sponsor study identifier
observational
885
1 country
1
Study Start
August 21, 2020
Actual (reported)Primary Completion
September 13, 2020
Actual (reported)Study Completion
September 13, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2020
Actual (reported)August 25, 2020
Actual (reported)August 26, 2020
Actual (reported)September 13, 2020
Actual (reported)September 13, 2020
Actual (reported)Number of ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019
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
Regional difference in ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019
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
3 months
Likelihood of restrictions leading to non-admittance of ELGAN
3 months
Extremely premature infants (GA\<28)
Contact the study team to confirm eligibility.
Neonatalklinikken, Rigshospitalet
Copenhagen, Denmark
Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Cheng G, Guimaraes H, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Lemmers P, Fredly S, Szczapa T, Austin T, Jakobsen JC, Greisen G. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. Trials. 2019 Dec 30;20(1):811. doi: 10.1186/s13063-019-3955-6.
Rasmussen MI, Hansen ML, Pichler G, Dempsey E, Pellicer A, El-Khuffash A, A S, Piris-Borregas S, Alsina M, Cetinkaya M, Chalak L, Ozkan H, Baserga M, Sirc J, Fuchs H, Ergenekon E, Arruza L, Mathur A, Stocker M, Otero Vaccarello O, Szczapa T, Sarafidis K, Krolak-Olejnik B, Memisoglu A, Reigstad H, Rafinska-Wazny E, Hatzidaki E, Peng Z, Gkentzi D, Viellevoye R, De Buyst J, Mastretta E, Wang P, Hahn GH, Bender L, Cornette L, Tkaczyk J, Del Rio R, Fumagalli M, Papathoma E, Wilinska M, Naulaers G, Sadowska-Krawczenko I, Lecart C, Couce ML, Fredly S, Heuchan AM, Karen T, Greisen G. Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown. Front Pediatr. 2021 Jul 12;9:647880. doi: 10.3389/fped.2021.647880. eCollection 2021.
Gorm Greisen, MD, Prof
Copenhagen University Hospital, Rigshospitalet
885 participants (actual enrollment reported by the registry).
First Submitted
August 25, 2020
First Posted
August 26, 2020
Study Start
August 21, 2020
Actual (reported)Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System
Primary Completion
September 13, 2020
Actual (reported)Study Completion
September 13, 2020
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
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