HypophosphatemiaNCT04814641
Hypophosphatemia and Bronchiolitis
An observational study of Hypophosphatemia and Bronchiolitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Read more about this study
- Who is it for?
- Ages 7 days to 3 months
- Conditions the study is for
- Hypophosphatemia, Bronchiolitis
- What is being tested?
- hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2021to Jun 2021
- 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 7 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit
Who may be able to join
- Age > 7 days and < 3 months of life
- Admission to the pediatric intensive care unit from 01/11/2016 to 31/03/2020
- With a diagnosis of moderate to severe bronchiolitis according to HAS 2019 criteria
Who cannot join
- Renal Failure and tubulopathy
- Previous disorder of phospho-calcium balance
- Malignant pathology
- Lenght of stay less than 24 hours
- History of cardiac, aortic or hepatic surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Femme Mere Enfant - Groupement Hospitalier Est
Bron, 69677
Florent Baudin, Dr, 4 72 12 97 35 ext. +33, florent.baudin@chu-lyon.fr
About this study
Official title: Hypophosphatemia In Infants With Severe Bronchiolitis: Prevalence And Risk Factors
Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.
- Conditions
- Hypophosphatemia, Bronchiolitis
- Being tested
- hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit
- Keywords
- Hypophosphatemia, Bronchiolitis, Paediatric Intensive Care Unit, Risk Factor
- Medical subject headings
- Hypophosphatemia, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unitBiological
Serum phosphorus level < 1.55 mmol/L at any time between admission and the 5th day.
| Study group | Role | What they receive |
|---|---|---|
| Infants with hypophosphatemia | Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit, with hypophosphatemia in the first 5th days Receives: Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit | |
| Infants without hypophosphatemia | Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit, without hypophosphatemia Receives: Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypophosphatemia occurrence in severe bronchiolitis in infants admitted in a pediatric intensive care unit
A serum phosphorus level< 1.55mmol/L defines the hypophosphatemia.
Measured: At any time in the first 5th days after Pediatric intensive care admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start21 Mar 2021
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814641
- Sponsor's protocol ID
- A289
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophosphatemia In Infants With Severe Bronchiolitis: Prevalence And Risk Factors
- ClinicalTrials.gov ID
- NCT04814641
- Acronym / sponsor ID
- A289
- Conditions
- Hypophosphatemia, Bronchiolitis
- Keywords
- Hypophosphatemia, Bronchiolitis, Paediatric Intensive Care Unit, Risk Factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Mar 2021 (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.
Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with hypophosphatemia | – | Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unitInfant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit, with hypophosphatemia in the first 5th days |
| Infants without hypophosphatemia | – | Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unitInfant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit, without hypophosphatemia |
Who may qualify
- Ages
- 7 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit
Key inclusion criteria (3 listed)
- Age > 7 days and < 3 months of life
- Admission to the pediatric intensive care unit from 01/11/2016 to 31/03/2020
- With a diagnosis of moderate to severe bronchiolitis according to HAS 2019 criteria
Key exclusion criteria (5 listed)
- Renal Failure and tubulopathy
- Previous disorder of phospho-calcium balance
- Malignant pathology
- Lenght of stay less than 24 hours
- History of cardiac, aortic or hepatic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unitSerum phosphorus level < 1.55 mmol/L at any time between admission and the 5th day. | Biological | Infants with hypophosphatemia, Infants without hypophosphatemia |
Primary outcome
hypophosphatemia occurrence in severe bronchiolitis in infants admitted in a pediatric intensive care unit
Time frame: At any time in the first 5th days after Pediatric intensive care admission
A serum phosphorus level< 1.55mmol/L defines the hypophosphatemia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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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.
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 Hypophosphatemia and Bronchiolitis, run by Hospices Civils de Lyon 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florent Baudin, Dr (4 72 12 97 35 ext. +33, florent.baudin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypophosphatemia occurrence in severe bronchiolitis in infants admitted in a pediatric intensive care unit (time frame: At any time in the first 5th days after Pediatric intensive care admission). 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 24 Mar 2021; AzTrials last refreshed its copy on 2 Nov 2026.