GastroenteritisNCT06211621
Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic
An observational study of Gastroenteritis and Rota Virus Gastroenteritis, run by Region Zealand at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Gastroenteritis, Rota Virus Gastroenteritis, Dehydration in Children
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Paediatrics and Adolescent Medicine
Slagelse, 4200
About this study
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.
Read more
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.
Read the detailed description
Admission patterns among children with non-Covid gastro-intestinal infections before and during the Covid-19 pandemic
- Purpose To compare incidence of and clinical characteristics of children admitted with gastro-intestinal infections during the Covid-19 pandemic relative to prepandemic seasons.
This will improve understanding of the indirect effects of the Covid-19 pandemic
HYPOTESES
- During the winter-spring months after the lock-down in 2020 fewer children were admitted with gastro-intestinal infections, relative to the winter-spring months of the pre-pandemic years, while more children were admitted during the winter-spring season of 2021 relative to pre-pandemic years.
- Children admitted during the winter-spring season of 2021 were more severely ill, and older than children admitted during the prepandemic seasons.
- BACKGROUND During the COVID-19 pandemic, admission patterns for infections other than Covid-19 have changed dramatically among children worldwide. [1][2]
During the first lockdown of 2020 a dramatic decline in children admitted with infections other than Covid-19 was reported worldwide. [1] Initially, concerns was expressed that this decline could be due to fear of seeking health care, or other barriers to access health care. For example, children with newly diagnosed diabetes in Germany were reported to present with ketoacidosis more frequently than before the pandemic. [3] [4] However, the main reason is likely to be reduced social contact limiting the spread of many other infections.
Later, reports of delayed epidemics - for example, the expected annual epidemic of respiratory syncytial virus did not occur in the winter of 2021, only to occur later and unexpectedly in the summer. This was first reported in Australia, and later in the Northern hemisphere, including Denmark [5][6].
Particularly admissions due to respiratory infections and later invasive streptococcal infections have been well documented.
Annual epidemics of viral gastrointestinal infections are known to occur in children in the winter and spring months, most caused by rotavirus infections. In the spring of 2021 many Danish paediatricians experienced an unusual surge of children admitted with gastroenteritis, and the general impressioin was that children werre older and more severely dehydrated than during previous seasons.
However, it has not yet been assessed whether gastroenteritis rates were indeed higher in 2021 during the pandemic, compared to the previous years, and whether the admitted children differed from children admitted before the pandemic.
Accordingly, this is what is planned to investigate with the current project.
Hopefully, the project may improve understanding of how well-known and regular epidemics are affected indirectly by the emergence of new diseases - and by the public health measures applied to prevent its spread. This may potentially inform management of future pandemics to reduce the harms, directly as well as indirectly.
- METHODS Study design
Retrospective review of patient files among children admitted with gastrointestinal infections in the paediatric department of Slagelse Hospital, during the spring-winter months (january to june) of three periods:
- pre-pandemic: january - june of 2017, 2018 and 2019 as well as january and february of 2020
- early pandemic: march-june 2020
- late pandemic: january - june of 2021
Participants:
Children aged from >1 months to <5 years with symptoms of gastroenteritis admitted to the paediatric department in Slagelse Hospital
Patient files will be identified in the electronic health record (EPIC) by a search of diagnoses such as "gastroenteritis", "rotavirus", "vomiting", "diarrhea", "dehydration". Each patient file will be evaluated by a doctor, and the child will be included if it is confirmed that the child was admitted with symptoms of gastrointestinal infection.
Data From the identified patient files anonymized data will be retrieved on age, gender, preexisting disease, past history, family type, breastfeeding, nutritional status, estimated degree of dehydration, as well as symptoms and clinical findings on admission, treatment given, duration of admission as well as microbiology and biochemical data.
Handling of data Data will be handles according to GDPR regulations. Anonymized data will be entered into a secured database (RedCAP) and analysed using the statistical package Stata.
- Funding The Slagelse hospitals research fund has funded three months of salary for a junior doctor and a medical student to type data and conduct the study
- Ethical issues and authorisation: The project has been registered on the research directory of Region Zealand (Regions Sjællands Interne Forskningsfortegnelse, no. REG-087-2021.)
The committee of research ethics of Region Zealand has stated that the study does not need reaserch ethical approval according to Danish Law, as it only involves retrieval of data from hospital files.
Regions Zealand has approved that anonymized data is collected from patient files without consent from the parents (Ref nr: R-21041034)
- PUBLICATION OF RESULTS The results of the project (whether positive, negative or inconclusive) will be submitted for publication to a peer reviewed scientific journal.
- Conditions
- Gastroenteritis, Rota Virus Gastroenteritis, Dehydration in Children, Infectious Disease, COVID-19 Pandemic, Norovirus Infections
- Keywords
- gastroenteritis, indirect effects, lockdown, epidemic, pandemic, children, Denmark, dehydration, diarrhea
- Medical subject headings
- Gastroenteritis, Communicable Diseases, COVID-19, Caliciviridae Infections, Dehydration, Diarrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of admission with gastroeneteritis in children
number of children admitted/1000 children per month
Measured: five years (2017 to 2021)
Secondary outcomes (2)
age of children admitted
age in month
Measured: five years (2017 to 2021)
severity of illness
proportion treated with IV fluids, base excess in blood, duration of admission
Measured: five years (2017 to 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2017
- Primary completionDec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maren Rytter, Region Zealand
- Investigators
- Maren Rytter, PhD, Principal investigator, Region Sjæland, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211621
- Sponsor's protocol ID
- R-21041034
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made available to other researchers upon request
Publications
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.
PubMed 33093429Kadambari 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.
PubMed 32852351Kamrath 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.
PubMed 32702751Foley 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.
PubMed 33594407Polcwiartek 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.
PubMed 33555426Nygaard 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.
PubMed 36634692Fischer 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.
PubMed 21386748
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT06211621
- Acronym / sponsor ID
- R-21041034
- Conditions
- Gastroenteritis, Rota Virus Gastroenteritis, Dehydration in Children, Infectious Disease, COVID-19 Pandemic, Norovirus Infections
- Keywords
- gastroenteritis, indirect effects, lockdown, epidemic, pandemic, children, Denmark, dehydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Admission patterns among children with non-Covid gastro-intestinal infections before and during the Covid-19 pandemic
- Purpose To compare incidence of and clinical characteristics of children admitted with gastro-intestinal infections during the Covid-19 pandemic relative to prepandemic seasons.
This will improve understanding of the indirect effects of the Covid-19 pandemic
HYPOTESES
- During the winter-spring months after the lock-down in 2020 fewer children were admitted with gastro-intestinal infections, relative to the winter-spring months of the pre-pandemic years, while more children were admitted during the winter-spring season of 2021 relative to pre-pandemic years.
- Children admitted during the winter-spring season of 2021 were more severely ill, and older than children admitted during the prepandemic seasons.
- BACKGROUND During the COVID-19 pandemic, admission patterns for infections other than Covid-19 have changed dramatically among children worldwide. [1][2]
During the first lockdown of 2020 a dramatic decline in children admitted with infections other than Covid-19 was reported worldwide. [1] Initially, concerns was expressed that this decline could be due to fear of seeking health care, or other barriers to access health care. For example, children with newly diagnosed diabetes in Germany were reported to present with ketoacidosis more frequently than before the pandemic. [3] [4] However, the main reason is likely to be reduced social contact limiting the spread of many other infections.
Later, reports of delayed epidemics - for example, the expected annual epidemic of respiratory syncytial virus did not occur in the winter of 2021, only to occur later and unexpectedly in the summer. This was first reported in Australia, and later in the Northern hemisphere, including Denmark [5][6].
Particularly admissions due to respiratory infections and later invasive streptococcal infections have been well documented.
Annual epidemics of viral gastrointestinal infections are known to occur in children in the winter and spring months, most caused by rotavirus infections. In the spring of 2021 many Danish paediatricians experienced an unusual surge of children admitted with gastroenteritis, and the general impressioin was that children werre older and more severely dehydrated than during previous seasons.
However, it has not yet been assessed whether gastroenteritis rates were indeed higher in 2021 during the pandemic, compared to the previous years, and whether the admitted children differed from children admitted before the pandemic.
Accordingly, this is what is planned to investigate with the current project.
Hopefully, the project may improve understanding of how well-known and regular epidemics are affected indirectly by the emergence of new diseases - and by the public health measures applied to prevent its spread. This may potentially inform management of future pandemics to reduce the harms, directly as well as indirectly.
- METHODS Study design
Retrospective review of patient files among children admitted with gastrointestinal infections in the paediatric department of Slagelse Hospital, during the spring-winter months (january to june) of three periods:
- pre-pandemic: january - june of 2017, 2018 and 2019 as well as january and february of 2020
- early pandemic: march-june 2020
- late pandemic: january - june of 2021
Participants:
Children aged from >1 months to <5 years with symptoms of gastroenteritis admitted to the paediatric department in Slagelse Hospital
Patient files will be identified in the electronic health record (EPIC) by a search of diagnoses such as "gastroenteritis", "rotavirus", "vomiting", "diarrhea", "dehydration". Each patient file will be evaluated by a doctor, and the child will be included if it is confirmed that the child was admitted with symptoms of gastrointestinal infection.
Data From the identified patient files anonymized data will be retrieved on age, gender, preexisting disease, past history, family type, breastfeeding, nutritional status, estimated degree of dehydration, as well as symptoms and clinical findings on admission, treatment given, duration of admission as well as microbiology and biochemical data.
Handling of data Data will be handles according to GDPR regulations. Anonymized data will be entered into a secured database (RedCAP) and analysed using the statistical package Stata.
- Funding The Slagelse hospitals research fund has funded three months of salary for a junior doctor and a medical student to type data and conduct the study
- Ethical issues and authorisation: The project has been registered on the research directory of Region Zealand (Regions Sjællands Interne Forskningsfortegnelse, no. REG-087-2021.)
The committee of research ethics of Region Zealand has stated that the study does not need reaserch ethical approval according to Danish Law, as it only involves retrieval of data from hospital files.
Regions Zealand has approved that anonymized data is collected from patient files without consent from the parents (Ref nr: R-21041034)
- PUBLICATION OF RESULTS The results of the project (whether positive, negative or inconclusive) will be submitted for publication to a peer reviewed scientific journal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of admission with gastroeneteritis in children
Time frame: five years (2017 to 2021)
number of children admitted/1000 children per month
2 secondary outcomes
age of children admitted
Time frame: five years (2017 to 2021)
severity of illness
Time frame: five years (2017 to 2021)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 33093429Gavish 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.
- Background: PubMed 32852351Kadambari 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.
- Background: PubMed 32702751Kamrath 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.
- Background: PubMed 33594407Foley 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.
- Background: PubMed 33555426Polcwiartek 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.
- Background: PubMed 36634692Nygaard 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.
- Background: PubMed 21386748Fischer 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available to other researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maren Rytter, PhD principal investigator
Region Sjæland, Slagelse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis and Rota Virus Gastroenteritis, run by Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of admission with gastroeneteritis in children (time frame: five years (2017 to 2021)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211621, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.