Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04209088
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2019-12-20
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
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDYSPE
Brief Summary:
Each year between 50000 and 60000 children are born prematurely in France Among them 10 are born at 26 - 30 weeks gestation and 5 are born before 26 weeks 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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None