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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)

Primary Purpose

Bronchopulmonary Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulmonary ultrasounds
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring bronchopulmonary dysplasia, premature newborn, ultrasonography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary ultrasounds

Arm Description

All patients will be included in the experimental arm

Outcomes

Primary Outcome Measures

Evaluate the AUC of the modified LUS score to predict the occurrence of BPD

Secondary Outcome Measures

Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Concordance of measured LUS scores between operator and reviewer
Concordance of measured LUS scores between operator and reviewer

Full Information

First Posted
December 20, 2019
Last Updated
May 30, 2022
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT04209088
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
Acronym
PREDYSPE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
June 6, 2023 (Anticipated)
Study Completion Date
June 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
bronchopulmonary dysplasia, premature newborn, ultrasonography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary ultrasounds
Arm Type
Experimental
Arm Description
All patients will be included in the experimental arm
Intervention Type
Other
Intervention Name(s)
Pulmonary ultrasounds
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Time Frame
Day 9
Secondary Outcome Measure Information:
Title
Evaluate the AUC of the modified LUS score to predict the occurrence of BPD
Time Frame
Day 15
Title
Concordance of measured LUS scores between operator and reviewer
Time Frame
Day 9
Title
Concordance of measured LUS scores between operator and reviewer
Time Frame
Day 15

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline HANGARD, Doctor
Phone
+33 (0) 555 058 666
Email
pauline.hangard@chu-limoges.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure PONTHIER, Doctor
Phone
+33 (0) 555 058 666
Email
laure.ponthier@chu-limoges.fr
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline HANGARD, Dr
Email
pauline.hangard@chu-limoges.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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