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

NCT04527601 | Completed

• 1 other identifier: SafeBoosC COVID-19 ELGAN study
• Study Type: observational
• Target: 885
• Locations: 1 country
• Sites: 1

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.

Conditions

Extreme Prematurity; Covid19

Keywords

extreme prematurity; safeboosc; RCT; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Likelihood of restrictions leading to non-admittance of ELGAN

  3 months

Study Arms (2)

ELGAN admissions during peak three months of COVID-19 pandemic

ELGAN admissions in the three corresponding months of 2019

Eligibility Criteria

• Age: 22 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Extremely premature infants (GA\<28)

You may qualify if:

• Extremely low gestational age neonates admitted to participating NICUs

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Neonatalklinikken, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (2)

• 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.

  PMID: 31888764 BACKGROUND

• 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.

  PMID: 34322460 DERIVED

Related Links

• trial website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gorm Greisen, MD, Prof

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 26, 2020
• Study Start: August 21, 2020
• Primary Completion: September 13, 2020
• Study Completion: September 13, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)