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Epidemiological Study of the Microbiota in Critically Ill Children

NCT04435470 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-04-01

No results posted yet for this study

Summary

Objectives: To study the composition of the microbiota in critically ill children, and to know the relationship of its microbiota with clinical complications and inflammation biomarkers.

Design: Multicenter observational and prospective study including 100 critically ill children admitted in three pediatric intensive care units with a prediction of more than 5 days of stay and 50 healthy children. Clinical parameters and rectal, fecal, blood and respiratory samples will be collected at admission and at pediatric intensive care units discharge. The microbiota and inflammation biomarkers and metabolomic will be analyzed.

Analysis of results: Description an evolution of the microbiota throughout the time, intestinal and respiratory, and the influence of clinical and therapeutic factors will be analyzed. The composition of microbiota will be compared with a cohort of healthy children and between the different types of pediatric intensive care units. The correlation of the microbiota with the markers of inflammation, metabolomics and the development of infectious complications and multiorgan failure will be analyzed.

Conditions

  • Critical Illness
  • Child, Only
  • Intensive Care Unit

Sponsors & Collaborators

  • Hospital Materno-Infantil Torrecárdenas de Almería

    collaborator UNKNOWN

  • Hospital Materno-Infantil de Málaga

    collaborator OTHER

  • Complejo Hospitalario Universitario de Santiago

    collaborator OTHER

  • University Hospital Virgen de las Nieves

    collaborator OTHER

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • MARÍA DOLORES MESA GARCÍA, PhD · Universidad de Granada

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-02-28
Completion
2023-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435470 on ClinicalTrials.gov