Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

— FunDyP  

Official title:

Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia: Myth or Reality? Retrospective Study of Premature Infants Inferior to 29 Weeks of Gestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152875
• Other study ID #: 2021/0060
• Status: Completed
• Start date: March 21, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Gender: All
• Age group: 1 Day to 29 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Extreme Prematurity
• Fungal Infection
• Hyperplasia
• Mycoses

Intervention

Other:
• biological
fungal colonization by weekly cultures

Locations

Country	Name	City	State
France	LAMOUCHI Mohamed Taher	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation	Need of nCPAP, NIPPV, or nasal cannula =3 L/min with more than 30% of fraction inspired in Oxygen.	at 36 weeks corrected age
Secondary	Necrotizing enterocolitis	Necrotizing enterocolitis	Day 0
Secondary	Intraventricular haemorrhage grade 3 or 44	Intraventricular haemorrhage grade 3 or 44	Day 0
Secondary	Retinopathy of prematurity	Retinopathy of prematurity	Day 0
Secondary	Invasive fungal infection	Invasive fungal infection	Day 0
Secondary	Death	Death	Day 0