Informations générales (source: ClinicalTrials.gov)
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 (PREDYSPE)
Interventional
N/A
University Hospital, Limoges (Voir sur ClinicalTrials)
mai 2020
juin 2023
29 juin 2024
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| University Hospital - 87042 - Limoges - France | Pauline HANGARD, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- Cardiac malformations
- Congenital lung malformation.