Epidemiological Study of the Microbiota in Critically Ill Children

NCT04435470 | Completed

• 2 other identifiers: BIOUCIPPI18/01334
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

microbiota; inflammation; metabolomic

Outcome Measures

Primary Outcomes (1)

• To identify intestinal and respiratory microbiota and if their changes are related with digestive and infectious complications

  To analyse the intestinal and respiratory microbiota in critically ill children admitted to the pediatric intensive care unit through massive sequencing, and evaluate if their changes are related with the appearance of digestive and infectious complications and the development of multiorgan failure.

  At admission and through study completion, at least 5 days

Secondary Outcomes (10)

• To compare intestinal and respiratory microbiota of critically ill children with a cohort of healthy children

  Samples will be taken at admission to pediatric intensive care unit and a single sample witl be taken from healthy controls

• To study the clinical factors influencing the changes in the intestinal microbiota during admission to the pediatric intensive care unit

  At admission and through study completion, at least 5 days

• To compare the changes of the microbiota according to the type of critical patients and the type of pediatric intensive care unit

  At admission and through study completion, at least 5 days

• To assess the relationship between changes in the intestinal microbiota and the frequency and severity of digestive complications

  At admission and through study completion, at least 5 days

• To study the relationship between changes in the intestinal and respiratory microbiota and the frequency and severity of nosocomial infection

  At admission and through study completion, at least 5 days

Study Arms (2)

Critical ill children

Critial ill children admited in pediatric intensive care units 1-16 years old

Control

Healthy children 1-16 years old

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Critical ill children admited to pediatric intensive care unit, with a hospitalization time expectancy more than 5 days Control subjects will be healthy children

You may qualify if:

• admission to pediatric intensive care unit
• hospitalization time expectancy more than 5 days
• age between 1 month and 16 years
• informed consent signed

You may not qualify if:

• hospitalization time expectancy less than 5 days
• no signed informed consent

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital Materno-Infantil Torrecárdenas de Almería: collaborator
• Hospital Materno-Infantil de Málaga: collaborator
• Complejo Hospitalario Universitario de Santiago: collaborator
• University Hospital Virgen de las Nieves: collaborator

Study Sites (1)

María Dolores Mesa García

Armilla, Granada, 18071, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Feces Saliva

MeSH Terms

Conditions

Critical Illness; Inflammation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MARÍA DOLORES MESA GARCÍA, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: June 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: July 31, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)