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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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