Brief 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
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
Brief 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.
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 Type
Interventional
Primary Outcome
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Secondary Outcome
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Condition
Bronchopulmonary Dysplasia
Intervention
Pulmonary ultrasounds
Study Arms / Comparison Groups
Pulmonary ultrasounds
Description: All patients will be included in the experimental arm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
218
Start Date
February 19, 2020
Completion Date
March 6, 2022
Primary Completion Date
March 6, 2022
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cardiac malformations
- Congenital lung malformation.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, +33 (0) 555 058 666, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04209088
Organization ID
87RI19_0023 (PREDYSPE)
Responsible Party
Sponsor
Study Sponsor
University Hospital, Limoges
Study Sponsor
, ,
Verification Date
February 2020