Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary ultrasounds | Experimental | All patients will be included in the experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary ultrasounds | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the AUC of the modified LUS score to predict the occurrence of BPD | Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the AUC of the modified LUS score to predict the occurrence of BPD | Day 15 | |
| Concordance of measured LUS scores between operator and reviewer | Day 9 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pauline HANGARD, Doctor | Contact | +33 (0) 555 058 666 | pauline.hangard@chu-limoges.fr | |
| Laure PONTHIER, Doctor | Contact | +33 (0) 555 058 666 | laure.ponthier@chu-limoges.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Limoges | 87042 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Concordance of measured LUS scores between operator and reviewer |
| Day 15 |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided