Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05152875

Acronym

FunDyP

Enrollment

153

Registered

2021-12-10

Start date

2022-03-21

Completion date

2022-05-31

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Extreme Prematurity, Fungal Infection

Keywords

Extremely premature infants, Bronchopulmonary dysplasia, fungal infection

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.

Interventions

OTHERbiological

fungal colonization by weekly cultures

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 29 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Necrotizing enterocolitis	Day 0	Necrotizing enterocolitis
Intraventricular haemorrhage grade 3 or 44	Day 0	Intraventricular haemorrhage grade 3 or 44
Retinopathy of prematurity	Day 0	Retinopathy of prematurity
Invasive fungal infection	Day 0	Invasive fungal infection
Death	Day 0	Death

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026