NCT06211621

Brief Summary

During the Covid-19 pandemic, admission patterns for infections other than Covid-19 have changed dramatically among children worldwide. Particularly admissions due to respiratory infections and later invasive streptococcal infections have been well documented. However, few studies have compared rates af gastro-intestinal infections during the pandemic with the previous years. This study aims to compare the number and characteristics of children hospitalized with gastrointestinal infections before the COVID-19 pandemic, to the first strict lockdown in 2020 and to the second, less strict lockdown in 2021. A retrospective review of medical records will be performed, of patients aged 1 month to 5 years admitted with gastroenteritis at the pediatric department at Slagelse Hospital in Denmark over a period from 2017 to 2021.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

6.9 years

First QC Date

December 29, 2023

Last Update Submit

January 17, 2024

Conditions

Keywords

gastroenteritisindirect effectslockdownepidemicpandemicchildrenDenmarkdehydrationdiarrhea

Outcome Measures

Primary Outcomes (1)

  • incidence of admission with gastroeneteritis in children

    number of children admitted/1000 children per month

    five years (2017 to 2021)

Secondary Outcomes (2)

  • age of children admitted

    five years (2017 to 2021)

  • severity of illness

    five years (2017 to 2021)

Eligibility Criteria

Age1 Month - 59 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged \>1 month and \<5 years admitted with symptoms of gastroenteritis at Slagelse Hospital during the months of january-june of 2017, 2018, 2019, 2020 and 2020

You may qualify if:

  • Children admitted to Slagelse hospital
  • aged \>1 month and \<5 years
  • symptoms of gastrointestinal infection
  • admitted during the months of january-june of 2017, 2018, 2019, 2020 and 2020

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics and Adolescent Medicine

Slagelse, 4200, Denmark

Location

Related Publications (7)

  • Gavish R, Krause I, Goldberg L, Bilavsky E, Kadmon G, Livni G, Scheuerman O, Levinsky Y. A Drop in Number of Hospitalizations Among Children with Bacterial Infections During the COVID-19 Pandemic. Pediatr Infect Dis J. 2021 Jan;40(1):e39-e41. doi: 10.1097/INF.0000000000002963.

    PMID: 33093429BACKGROUND
  • Kadambari S, Abo YN, Phuong LK, Osowicki J, Bryant PA. Decrease in Infection-related Hospital Admissions During COVID-19: Why Are Parents Avoiding the Doctor? Pediatr Infect Dis J. 2020 Nov;39(11):e385-e386. doi: 10.1097/INF.0000000000002870. No abstract available.

    PMID: 32852351BACKGROUND
  • Kamrath C, Monkemoller K, Biester T, Rohrer TR, Warncke K, Hammersen J, Holl RW. Ketoacidosis in Children and Adolescents With Newly Diagnosed Type 1 Diabetes During the COVID-19 Pandemic in Germany. JAMA. 2020 Aug 25;324(8):801-804. doi: 10.1001/jama.2020.13445.

    PMID: 32702751BACKGROUND
  • Foley DA, Yeoh DK, Minney-Smith CA, Martin AC, Mace AO, Sikazwe CT, Le H, Levy A, Moore HC, Blyth CC. The Interseasonal Resurgence of Respiratory Syncytial Virus in Australian Children Following the Reduction of Coronavirus Disease 2019-Related Public Health Measures. Clin Infect Dis. 2021 Nov 2;73(9):e2829-e2830. doi: 10.1093/cid/ciaa1906. No abstract available.

    PMID: 33594407BACKGROUND
  • Polcwiartek LB, Polcwiartek C, Andersen MP, Ostergaard L, Broccia MD, Gislason GH, Kober L, Torp-Pedersen C, Schou M, Fosbol E, Kragholm K, Hagstrom S. Consequences of coronavirus disease-2019 (COVID-19) lockdown on infection-related hospitalizations among the pediatric population in Denmark. Eur J Pediatr. 2021 Jun;180(6):1955-1963. doi: 10.1007/s00431-021-03934-2. Epub 2021 Feb 8.

    PMID: 33555426BACKGROUND
  • Nygaard U, Hartling UB, Nielsen J, Vestergaard LS, Dungu KHS, Nielsen JSA, Sellmer A, Matthesen AT, Kristensen K, Holm M. Hospital admissions and need for mechanical ventilation in children with respiratory syncytial virus before and during the COVID-19 pandemic: a Danish nationwide cohort study. Lancet Child Adolesc Health. 2023 Mar;7(3):171-179. doi: 10.1016/S2352-4642(22)00371-6. Epub 2023 Jan 9.

    PMID: 36634692BACKGROUND
  • Fischer TK, Rungoe C, Jensen CS, Breindahl M, Jorgensen TR, Nielsen JP, Jensen L, Malon M, Braendholt V, Fisker N, Hjelt K. The burden of rotavirus disease in Denmark 2009-2010. Pediatr Infect Dis J. 2011 Jul;30(7):e126-9. doi: 10.1097/INF.0b013e3182145277.

    PMID: 21386748BACKGROUND

MeSH Terms

Conditions

GastroenteritisCommunicable DiseasesCOVID-19Caliciviridae InfectionsDehydrationDiarrhea

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Maren Rytter, PhD

    Region Sjæland, Slagelse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, PhD, clinical associate professor

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 18, 2024

Study Start

January 1, 2017

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Anonymized data will be made available to other researchers upon request

Locations