Clinical trial NCT04435470: Epidemiological Study of the Microbiota in Critically Ill Children
Official title: Epidemiological Study of the Microbiota in Critically Ill Children and Its Relationship With Clinical Complications and Inflammation Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Child, Only
Intensive Care Unit
Keywords: microbiota
inflammation
metabolomic
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Materno-Infantil Torrecárdenas de Almería
name: Hospital Materno-Infantil de Málaga
name: Complejo Hospitalario Universitario de Santiago
name: University Hospital Virgen de las Nieves
First posted: 2020-06-17
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed description: AIM: The present study is an observational clinical study aimed to study the intestinal microbiota composition of critically ill children in paediatric intensive care unit and its relationship with clinical complications and inflammatory biomarkers.

DESIGN: This study is a multicentre, observational and prospective study including 100 critically ill children admitted in three paediatric intensive care units (Hospital Materno-Infantil Torrecárdenas de Almería, y en el Hospital Materno-Infantil Carlos Haya de Málaga and Complejo Hospitalario Universitario de Santiago) This study is a multicentre, observational and prospective study conducted by members of the Department of Biochemistry and Molecular Biology II, Nutrition and Food Technology Institute "José Mataix" of the University of Granada research group in collaboration with the Hospital Materno-Infantil Torrecárdenas from Almería, the Hospital Materno-Infantil Carlos Haya from Málaga and Complejo Hospitalario Universitario from Santiago de Compostela pediatric intensive care units and primary care unit of the University Hospital Virgen de las Nieves from Granada as recruitment centres.

This trial will include 100 critically ill children admitted from the three different pediatric intensive care units with an expected hospitalization time of more than 5 days. In addition, 50 healthy children will be recruited from a primary care centre as controls. Faecal and respiratory system (oropharynx) samples will be collected from ill and healthy children, while blood samples will be harvested only from critically ill children at the time of admission to the pediatric intensive care units as well as at the day of discharge. Sample aliquots will be sent to the Department of Biochemistry and Molecular Biology II, University of Granada for further analysis.

Study population The study population will comprise 50 healthy children aged between 1 month and 16 years, recruited in a paediatric primary care center from Granada, and 100 critically ill children admitted to the pediatric intensive care units aged between 1 month and 16 years. 50 patients will be recruited at the pediatric intensive care units of Hospital Materno-Infantil Torrecárdenas from Almería, the Hospital Materno-Infantil Carlos Haya from Málaga and Complejo Hospitalario Universitario from Santiago de Compostela. Only those children who satisfy all inclusion and none of exclusion criteria will be included in the study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To identify intestinal and respiratory microbiota and if their changes are related with digestive and infectious complications
timeFrame: At admission and through study completion, at least 5 days
Secondary outcomes:
measure: To compare intestinal and respiratory microbiota of critically ill children with a cohort of healthy children
timeFrame: Samples will be taken at admission to pediatric intensive care unit and a single sample witl be taken from healthy controls
measure: To study the clinical factors influencing the changes in the intestinal microbiota during admission to the pediatric intensive care unit
timeFrame: At admission and through study completion, at least 5 days
measure: To compare the changes of the microbiota according to the type of critical patients and the type of pediatric intensive care unit
timeFrame: At admission and through study completion, at least 5 days
measure: To assess the relationship between changes in the intestinal microbiota and the frequency and severity of digestive complications
timeFrame: At admission and through study completion, at least 5 days
measure: To study the relationship between changes in the intestinal and respiratory microbiota and the frequency and severity of nosocomial infection
timeFrame: At admission and through study completion, at least 5 days
measure: To study the relationship between changes in the intestinal and respiratory microbiota and the development of multiorgan failure
timeFrame: At admission and through study completion, at least 5 days
measure: To determine changes in the serum levels of lipopolysaccharide and lipopolysaccharide binding protein and to evaluate their relationship with intestinal and respiratory microbiota
timeFrame: At admission and through study completion, at least 5 days
measure: To analyse the relationship between changes in the intestinal and respiratory microbiota plasma sort chain fatty acids and bile acids
timeFrame: At admission and through study completion, at least 5 days
measure: To analyse the relationship between changes in microbiota and inflammatory biomarkers
timeFrame: At admission and through study completion, at least 5 days
measure: To assess the influence of the type of nutrition during admission and changes of intestinal microbiota
timeFrame: At admission and through study completion, at least 5 days
Other outcomes:
Locations:
city: Armilla
country: Spain
facility: María Dolores Mesa García
state: Granada
Study officials:
affiliation: Universidad de Granada
name: MARÍA DOLORES MESA GARCÍA, PhD
role: PRINCIPAL_INVESTIGATOR
References: