Clinical trial NCT05152875: Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia
Official title: Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia: Myth or Reality? Retrospective Study of Premature Infants Inferior to 29 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Extreme Prematurity
Fungal Infection
Keywords: Extremely premature infants
Bronchopulmonary dysplasia
fungal infection
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 153
Sex: ALL
Minimum age (years): 1
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort will be selected among all extremely premature infants admitted between January 2018 and December 2020 in the neonatal intensive care unit of Centre Hospitalier Sud Francilien (Corbeil Essonnes 91, France)

Brief summary: The aim of this study is to determine if fungal colonization is associated to severe bronchopulmonary dysplasia in premature infants less than 29 weeks of gestation, and to determine if an association exists between fungal colonization and complications of prematurity and death.

Detailed description: Fungal colonization is common in premature infants. Certain neonatal departments, routinely screen for fungal colonization by weekly cultures, while other departments perform fungal cultures solely in the presence of suggestive clinical or biological signs such as hyperleucocytosis, maternal vaginal candidiasis, sepsis and characteristic skin lesions. This neonatal colonization can progress to an invasive fungal infection leading to death and comorbidities. A relationship between fungal colonization and severe bronchopulmonary dysplasia is suspected.

Eligibility criteria: Inclusion Criteria:

* Premature infants inferior to 29 weeks of gestation screened for fungal colonization,
* Admitted in the neonatal department of Centre Hospitalier Sud Francilien,
* Between January 1st 2018 and December 31st 2020,
* Holders of parental authority informed of the study that are unopposed

Exclusion Criteria:

* Premature infants over 29 weeks of gestation, or term infants,
* Premature infants less than 29 weeks of gestation not screened for fungal colonization during their hospitalization,
* Premature infants with significant congenital malformations or genetic abnormalities,
* Premature infants inferior to 29 weeks of gestation deceased in delivery room.

Primary outcomes:
measure: Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation
timeFrame: at 36 weeks corrected age
Secondary outcomes:
measure: Necrotizing enterocolitis
timeFrame: Day 0
measure: Intraventricular haemorrhage grade 3 or 44
timeFrame: Day 0
measure: Retinopathy of prematurity
timeFrame: Day 0
measure: Invasive fungal infection
timeFrame: Day 0
measure: Death
timeFrame: Day 0
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: LAMOUCHI Mohamed Taher
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Mohamed Taher LAMOUCHI, MD
role: PRINCIPAL_INVESTIGATOR
References: