Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia

Completed

• Conditions: Extreme Prematurity; Bronchopulmonary Dysplasia; Fungal Infection

• Registration Number: NCT05152875
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-10
• Study Start: 2022-03-21
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-09
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation	at 36 weeks corrected age	Need of nCPAP, NIPPV, or nasal cannula ≥3 L/min with more than 30% of fraction inspired in Oxygen.

Secondary Outcome Measures

Name	Time	Method
Retinopathy of prematurity	Day 0	Retinopathy of prematurity
Necrotizing enterocolitis	Day 0	Necrotizing enterocolitis
Intraventricular haemorrhage grade 3 or 44	Day 0	Intraventricular haemorrhage grade 3 or 44
Invasive fungal infection	Day 0	Invasive fungal infection
Death	Day 0	Death

Trial Locations

Locations (1)

LAMOUCHI Mohamed Taher; 🇫🇷 Corbeil-essonnes Cedex, France