Acute GastroenteritisGEANCT04555200
Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis
An observational study of Acute Gastroenteritis and Dehydration, run by University Hospital, Brest at 1 site in France.
Trial summary
When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Acute Gastroenteritis, Dehydration
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 2 Oct 2019
- 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 day to 15 years
- All sexes
- Child
Study population: Any child from 0 to 15 years presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included
Who may be able to join
- Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included
Who cannot join
- acute gastroenteritis on return from tropical countries
- child with endocrine system diseases requiring parenteral rehydration
- history of chronic pathology requiring enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change
When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol
Read the detailed description
The main purpose was to assess the proportion of children rehydrated by nasogastric tube(NG) after protocol change. Secondary outcomes were to assess hospital length of stay and sides effects.
It is a retro and prospective study. The first phase took place from June to September 2018 and the second from June to September 2019. Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included.
- Conditions
- Acute Gastroenteritis, Dehydration
- Keywords
- nasogastric tube, Emergency medicine, Pediatric medicine
- Medical subject headings
- Dehydration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nasogastric tube after changing gastroenteritis rehydration protocol
assessed by the number of NG tube and IV in each group
Measured: 4 months
Secondary outcomes (2)
Hospital lenght of stay between each group
evaluate by administrative data of each case (arrival time and departure time)
Measured: 4 months
Number of Participants With Treatment-Related Adverse Events for each method
Serious sides effect were death and epilptic seizure. Mild sides effects were multiple (IV or NG ripped out, vomiting, failure...).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jun 2018
- Primary completion1 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadege Delaperriere, Doctor, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555200
- Sponsor's protocol ID
- 29BRC19.0130
- Acronym
- GEA
- Status last verified
- Sep 2019
- First submitted
- 6 Jul 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change
- ClinicalTrials.gov ID
- NCT04555200
- Acronym / sponsor ID
- GEA / 29BRC19.0130
- Conditions
- Acute Gastroenteritis, Dehydration
- Keywords
- nasogastric tube, Emergency medicine, Pediatric medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 18 Sep 2020 (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.
When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol
Detailed description
The main purpose was to assess the proportion of children rehydrated by nasogastric tube(NG) after protocol change. Secondary outcomes were to assess hospital length of stay and sides effects.
It is a retro and prospective study. The first phase took place from June to September 2018 and the second from June to September 2019. Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Any child from 0 to 15 years presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included
Key inclusion criteria (1 listed)
- Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included
Key exclusion criteria (3 listed)
- acute gastroenteritis on return from tropical countries
- child with endocrine system diseases requiring parenteral rehydration
- history of chronic pathology requiring enteral feeding
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
Number of nasogastric tube after changing gastroenteritis rehydration protocol
Time frame: 4 months
assessed by the number of NG tube and IV in each group
2 secondary outcomes
Hospital lenght of stay between each group
Time frame: 4 months
Number of Participants With Treatment-Related Adverse Events for each method
Time frame: 4 months
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 Sep 2020.
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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.
Nadege Delaperriere, Doctor principal investigator
CHRU BREST
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 Acute Gastroenteritis and Dehydration, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 3 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 Sep 2020. 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 France. 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?
Number of nasogastric tube after changing gastroenteritis rehydration protocol (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.