Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia (FunDyP)

November 22, 2024 updated by: Centre Hospitalier Sud Francilien

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-essonnes Cedex, France, 91106
        • LAMOUCHI Mohamed Taher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation
Time Frame: at 36 weeks corrected age
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Mohamed Taher LAMOUCHI, MD, Centre Hospitalier Sud Francilien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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