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Completed

NCT Number: NCT05152875

Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Extreme Prematurity Fungal Infection Infant, Newborn, Diseases Infant, Premature, Diseases Infections Lung Diseases Lung Injury Mycoses Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

1 day–29 day

Sex eligibility

All sexes

Study type

Observational

Primary location

LAMOUCHI Mohamed Taher

Corbeil-Essonnes, France, 91106

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological

Other

fungal colonization by weekly cultures

Primary outcomes

  1. 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.

Secondary outcomes

  1. Necrotizing enterocolitis

    Time frame: Day 0

    Necrotizing enterocolitis

  2. Intraventricular haemorrhage grade 3 or 44

    Time frame: Day 0

    Intraventricular haemorrhage grade 3 or 44

  3. Retinopathy of prematurity

    Time frame: Day 0

    Retinopathy of prematurity

  4. Invasive fungal infection

    Time frame: Day 0

    Invasive fungal infection

  5. Death

    Time frame: Day 0

    Death

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: FunDyP

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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