Bronchopulmonary DysplasiaFunDyPNCT05152875
Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia and Extreme Prematurity, run by Centre Hospitalier Sud Francilien at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 29 days
- Conditions the study is for
- Bronchopulmonary Dysplasia, Extreme Prematurity, Fungal Infection
- What is being tested?
- biological
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2022to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 29 days
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- biological
- Keywords
- Extremely premature infants, Bronchopulmonary dysplasia, fungal infection
- Medical subject headings
- Bronchopulmonary Dysplasia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologicalOther
fungal colonization by weekly cultures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 36 weeks corrected age
Secondary outcomes (5)
Necrotizing enterocolitis
Necrotizing enterocolitis
Measured: Day 0
Intraventricular haemorrhage grade 3 or 44
Intraventricular haemorrhage grade 3 or 44
Measured: Day 0
Retinopathy of prematurity
Retinopathy of prematurity
Measured: Day 0
Invasive fungal infection
Invasive fungal infection
Measured: Day 0
Death
Death
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start21 Mar 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Taher LAMOUCHI, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152875
- Sponsor's protocol ID
- 2021/0060
- Acronym
- FunDyP
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia: Myth or Reality? Retrospective Study of Premature Infants Inferior to 29 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT05152875
- Acronym / sponsor ID
- FunDyP / 2021/0060
- Keywords
- Extremely premature infants, Bronchopulmonary dysplasia, fungal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 29 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologicalfungal colonization by weekly cultures | Other | – |
Primary outcome
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.
5 secondary outcomes
Necrotizing enterocolitis
Time frame: Day 0
Intraventricular haemorrhage grade 3 or 44
Time frame: Day 0
Retinopathy of prematurity
Time frame: Day 0
Invasive fungal infection
Time frame: Day 0
Death
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Taher LAMOUCHI, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Extreme Prematurity, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation (time frame: at 36 weeks corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.