Hypophosphatemia and Bronchiolitis

March 22, 2021 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Hopital Femme Mère Enfant - Groupement Hospitalier Est
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit
Serum phosphorus level < 1.55 mmol/L at any time between admission and the 5th day.
Infants without hypophosphatemia
Infant less than 3 months with severe bronchiolitis admitted in a pediatric intensive care unit, without hypophosphatemia
Biological: hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit
Serum phosphorus level < 1.55 mmol/L at any time between admission and the 5th day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At any time in the first 5th days after Pediatric intensive care admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A289

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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