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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)

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ClinicalTrials.gov Identifier: NCT04209088
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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).


Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Other: Pulmonary ultrasounds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : March 6, 2022
Estimated Study Completion Date : March 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Pulmonary ultrasounds
All patients will be included in the experimental arm
Other: Pulmonary ultrasounds

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 Measures :
  1. Evaluate the AUC of the modified LUS score to predict the occurrence of BPD [ Time Frame: Day 9 ]

Secondary Outcome Measures :
  1. Evaluate the AUC of the modified LUS score to predict the occurrence of BPD [ Time Frame: Day 15 ]
  2. Concordance of measured LUS scores between operator and reviewer [ Time Frame: Day 9 ]
  3. Concordance of measured LUS scores between operator and reviewer [ Time Frame: Day 15 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209088


Contacts
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Contact: Pauline HANGARD, Doctor +33 (0) 555 058 666 pauline.hangard@chu-limoges.fr
Contact: Laure PONTHIER, Doctor +33 (0) 555 058 666 laure.ponthier@chu-limoges.fr

Locations
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France
University Hospital Recruiting
Limoges, France, 87042
Contact: Pauline HANGARD, Dr       pauline.hangard@chu-limoges.fr   
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04209088    
Other Study ID Numbers: 87RI19_0023 (PREDYSPE)
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
bronchopulmonary dysplasia
premature newborn
ultrasonography
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Premature Birth
Hyperplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases