Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia

NCT05152875 | Completed

• 1 other identifier: 2021/0060
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Extreme Prematurity; Fungal Infection

Keywords

Extremely premature infants; Bronchopulmonary dysplasia; fungal infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Necrotizing enterocolitis

  Day 0

• Intraventricular haemorrhage grade 3 or 44

  Day 0

• Retinopathy of prematurity

  Day 0

• Invasive fungal infection

  Day 0

• Death

  Day 0

Interventions

biological OTHER

fungal colonization by weekly cultures

Eligibility Criteria

• Age: 1 Day - 29 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

LAMOUCHI Mohamed Taher

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Mycoses

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Mohamed Taher LAMOUCHI, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 10, 2021
• Study Start: March 21, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 26, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)