NCT04814641

Brief 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. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 22, 2021

Last Update Submit

March 22, 2021

Conditions

Keywords

HypophosphatemiaBronchiolitisPaediatric Intensive Care UnitRisk Factor

Outcome Measures

Primary Outcomes (1)

  • hypophosphatemia occurrence in severe bronchiolitis in infants admitted in a pediatric intensive care unit

    A serum phosphorus level\< 1.55mmol/L defines the hypophosphatemia.

    At any time in the first 5th days after Pediatric intensive care admission

Study Arms (2)

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

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

Interventions

Serum phosphorus level \< 1.55 mmol/L at any time between admission and the 5th day.

Infants with hypophosphatemiaInfants without hypophosphatemia

Eligibility Criteria

Age7 Days - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mere Enfant - Groupement Hospitalier Est

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

HypophosphatemiaBronchiolitis

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

March 21, 2021

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations