Bronchopulmonary DysplasiaPREDYSPENCT04209088
Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation
A study testing Pulmonary ultrasounds in people with Bronchopulmonary Dysplasia, run by University Hospital, Limoges at 1 site in France.
Trial summary
Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation. Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Pulmonary ultrasounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2020to 6 Jun 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Premature neonates with gestational age less than or equal to 34 weeks of amenorrhea.
- Hospitalized in the NICU or neanatology unit at Limoges University Hospital at day 9 +/- 2 and day 15 +/- 2 of life
- participation agreement of at least one of the parents.
Who cannot join
- Cardiac malformations
- Congenital lung malformation.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Limoges, 87042
Pauline HANGARD, Dr, pauline.hangard@chu-limoges.fr
About this study
Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation.
Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams.
Read more
BPD is defined by the need for oxygen after 28 days of life in any children born prematurely. In addition, the severity of BPD can be categorized as mild (room air tolerated at 36 weeks), moderate (oxygen requirement between 22 and 29 %) and severe (oxygen requirement 30% or need for ventilation support).
Bronchopulmonary dysplasia is responsible for significant respiratory morbidity and impaired neurological outcomes.
Pulmonary imaging such as tomodensitometry, MRI or scintigraphy can be abnormal and therefore coud theorically be helpful for an early diagnosis. Unfortunatelly, theses examinations are irradiating, expensive or difficult to perform in an everyday practice. Therefore lung imaging for BPD diagnosis. Is not recommanded in current official guidelines.
Pulmonary ultrasound has already been studied in premature newborns. A pilot study carried out on 21 patients showed that pulmonary ultrasonography at one and two weeks of life could predict the risk of bronchopulmonary dysplasia. The score used in this study was the LUS score previously validated by Brat et al. Advantages of this examination are to be non-invasive and easily performed at the patient's bedside. Nevertheless this study focused on a small population with a low number of moderate / severe dysplasia.
In addition, Czernik et al. have highlighted that the index of myocardial performance of the right ventricle was increased at seven and ten days of life in children who subsequently developed BPD.
The investigators propose in this study to evaluate a new prediction score for DBP, the modified LUS score, associating the LUS score with an echographic evaluation of the right heart (myocardial performance index).
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Pulmonary ultrasounds
- Keywords
- bronchopulmonary dysplasia, premature newborn, ultrasonography
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary ultrasoundsOther
Two ultrasounds will be performed by the same pediatrician for each child included: the first at nine days of life +/- two days, the second at fifteen days of life +/- two days.
A blind replay of ultrasound images to calculate the score will be performed by a another investigator.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary ultrasounds | Experimental | All patients will be included in the experimental arm Receives: Other: Pulmonary ultrasounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Measured: Day 9
Secondary outcomes (3)
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Measured: Day 15
Concordance of measured LUS scores between operator and reviewer
Measured: Day 9
Concordance of measured LUS scores between operator and reviewer
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start29 May 2020
- Primary completion6 Jun 2023 (estimated)
- Study completion6 Jun 2023 (estimated)
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.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209088
- Sponsor's protocol ID
- 87RI19_0023 (PREDYSPE)
- Acronym
- PREDYSPE
- Status last verified
- May 2022
- First submitted
- 20 Dec 2019
- Last updated
- 1 Jun 2022
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT04209088
- Acronym / sponsor ID
- PREDYSPE / 87RI19_0023 (PREDYSPE)
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- bronchopulmonary dysplasia, premature newborn, ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 6 Jun 2023 (estimated)
- Study completion
- 6 Jun 2023 (estimated)
- First posted
- 23 Dec 2019 (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.
Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation.
Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams.
BPD is defined by the need for oxygen after 28 days of life in any children born prematurely. In addition, the severity of BPD can be categorized as mild (room air tolerated at 36 weeks), moderate (oxygen requirement between 22 and 29 %) and severe (oxygen requirement 30% or need for ventilation support).
Bronchopulmonary dysplasia is responsible for significant respiratory morbidity and impaired neurological outcomes.
Pulmonary imaging such as tomodensitometry, MRI or scintigraphy can be abnormal and therefore coud theorically be helpful for an early diagnosis. Unfortunatelly, theses examinations are irradiating, expensive or difficult to perform in an everyday practice. Therefore lung imaging for BPD diagnosis. Is not recommanded in current official guidelines.
Pulmonary ultrasound has already been studied in premature newborns. A pilot study carried out on 21 patients showed that pulmonary ultrasonography at one and two weeks of life could predict the risk of bronchopulmonary dysplasia. The score used in this study was the LUS score previously validated by Brat et al. Advantages of this examination are to be non-invasive and easily performed at the patient's bedside. Nevertheless this study focused on a small population with a low number of moderate / severe dysplasia.
In addition, Czernik et al. have highlighted that the index of myocardial performance of the right ventricle was increased at seven and ten days of life in children who subsequently developed BPD.
The investigators propose in this study to evaluate a new prediction score for DBP, the modified LUS score, associating the LUS score with an echographic evaluation of the right heart (myocardial performance index).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary ultrasounds | Experimental | Other: Pulmonary ultrasoundsAll patients will be included in the experimental arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Premature neonates with gestational age less than or equal to 34 weeks of amenorrhea.
- Hospitalized in the NICU or neanatology unit at Limoges University Hospital at day 9 +/- 2 and day 15 +/- 2 of life
- participation agreement of at least one of the parents.
Key exclusion criteria (2 listed)
- Cardiac malformations
- Congenital lung malformation.
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 |
|---|---|---|
| Pulmonary ultrasoundsTwo ultrasounds will be performed by the same pediatrician for each child included: the first at nine days of life +/- two days, the second at fifteen days of life +/- two days. A blind replay of ultrasound images to calculate the score will be performed by a another investigator. | Other | Pulmonary ultrasounds |
Primary outcome
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Time frame: Day 9
3 secondary outcomes
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Time frame: Day 15
Concordance of measured LUS scores between operator and reviewer
Time frame: Day 9
Concordance of measured LUS scores between operator and reviewer
Time frame: Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary ultrasounds in people with Bronchopulmonary Dysplasia, run by University Hospital, Limoges 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline HANGARD, Doctor (+33 (0) 555 058 666, pauline.hangard@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD (time frame: Day 9). 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 1 Jun 2022.