Ultrasound Assessment of Diaphragmatic Function in Infants With BPD

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Brief Title

Ultrasound Assessment of Diaphragmatic Function in Infants With BPD

Official Title

Functional Evaluation of the Diaphragm With Bedside Ultrasound in Infants With Bronchopulmonary Dysplasia: a Single Centre Prospective Trial

Brief Summary

      Extremely preterm infants have high and prolonged exposure to positive pressure ventilation,
      which contributes to acute lung injury and the development of bronchopulmonary dysplasia
      (BPD). Despite the risk of diaphragmatic dysfunction in infants with BPD, the effect of
      prolonged ventilator support on the diaphragmatic function of preterm infants has not been
      well characterized.

      Hence, we aim to characterize the diaphragmatic function of very preterm neonates with BPD
      who are corrected to ≥ 36 weeks using bedside ultrasound in comparison to healthy newborns
      born at ≥ 36 weeks gestation.
    

Detailed Description

      Study Design and setting; This is a prospective descriptive pilot study that will be
      conducted on infants born at ≤ 32 weeks gestation who meet eligibility criteria and are
      admitted to the neonatal intensive care at Mount Sinai Hospital and healthy newborns born at
      at ≥ 36 weeks gestation. Enrollment of eligible infants will start after obtaining approval
      from the Research Ethics Board at Mount Sinai Hospital and parental consent.

      Time of assessment; Parents of infants who are eligible for the study will be approached for
      consent. Chest ultrasound (lung ultrasound and diaphragmatic function assessment) will be
      performed at ≥ 36 weeks corrected gestational age. Chest ultrasound will be done before a
      feeding to avoid any concerns of a full stomach on diaphragmatic assessment.

      Study procedure; Functional assessment of the diaphragm combined with lung ultrasound
      examination will be done by one of the following investigators. A sample of 10-15
      consecutively selected infants will have lung ultrasound and diaphragmatic function
      assessment done twice by 2 operators (inter-rater variability will be measured at the end of
      the study). The operators will not be aware of the result of chest ultrasound done by the
      other operator for the same patient but consecutive exams will be conducted by 2 different
      operators in a time separated by one feed interval. Standard variables for assessing
      diaphragm function will be used including diaphragmatic thickness fraction, and diaphragmatic
      excursion (DE). Lung ultrasound severity score, diaphragmatic thickness fraction, and
      diaphragmatic excursion will be calculated. Inter-rater agreement will be assessed using raw
      percentage of agreement (Pa), Cohen's and Kappa (κ), and G wet agreement coefficient (AC1).
      Intra-class correlation (ICC) will be determined for variables with continuous measurements
      (mixed factorial design). High-resolution linear and curvilinear US probes of 20-5 and 10-3
      MegahertZ will be used to assess lung ultrasound score and to measure diaphragmatic thickness
      fraction, and diaphragmatic excursion [amplitude] respectively using both B and M modes.

      Lung ultrasound assessment technique; Lung ultrasounds will be performed in a standardized
      manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three
      chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed.
      Each area will have a score of 0 to 3 points with a total score between 0 to 18, which
      inversely correlates with lung aeration.

      Diaphragmatic assessment technique; Diaphragm assessment will be performed in the supine
      position. To measure diaphragmatic excursion, the curvilinear probe will be placed on the
      lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right
      side and between the anterior and mid-axillary lines for the left side. Using the B mode, the
      proper exploration line of the diaphragm will be detected by directing the beam perpendicular
      to the posterior third of the right hemidiaphragm. By M mode, the cyclic caudal diaphragmatic
      displacement with respiration will be measured as the perpendicular distance between the most
      caudal point of the liver or spleen at the end of expiration and the end of inspiration. The
      average of three respiratory cycles will be taken.

      The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated
      using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the
      apposition zone which can be obtained by placing the linear transducer above the 10th rib in
      the mid-axillary or anterior axillary lines in the right intercostal spaces. By B mode, three
      distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear
      echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower
      line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the
      maximum perpendicular distance between pleural and peritoneal layers and by the same way
      expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness fraction will be
      calculated using the following formula:

      diaphragmatic thickness fraction = [(inspiratory thickness - expiratory thickness)/expiratory
      thickness] x 100.

      The average of the calculated diaphragmatic thickness fraction from three respiratory cycles
      will be estimated. The higher scores the better the diaphragmatic function. All Chest
      ultrasound assessments will be undertaken using a standard aseptic technique.
    


Study Type

Observational


Primary Outcome

Evaluation of the diaphragmatic Thickness fraction and diaphragmatic excursion in neonates with bronchopulmonary dysplasia


Condition

Bronchopulmonary Dysplasia

Intervention

No intervention


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

100

Start Date

November 26, 2019

Completion Date

August 1, 2021

Primary Completion Date

July 15, 2021

Eligibility Criteria

        Inclusion Criteria:

        Cases:

          -  Infants who are born at ≤ 32 weeks gestation,

          -  Admitted to the neonatal intensive care at Mount Sinai Hospital

          -  Receiving oxygen or respiratory support at ≥ 36 weeks gestation

        Control:

          -  Infants who are born at ≥ 36 weeks gestation

          -  Admitted to the level 1 nursery.

          -  Informed consent obtained from parents or guardians prior to enrolment in the study.

        Exclusion Criteria:

          -  Infants who have congenital or chromosomal abnormalities.

          -  Parents declined the consent.
      

Gender

All

Ages

36 Weeks - N/A

Accepts Healthy Volunteers

No

Contacts

, 4165864800, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04941963

Organization ID

19-0224-E


Responsible Party

Sponsor

Study Sponsor

Mount Sinai Hospital, Canada


Study Sponsor

, , 


Verification Date

May 2021