Ultrasound Assessment of Diaphragmatic Function in Infants With BPD

March 15, 2023 updated by: Mount Sinai Hospital, Canada

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 will be done by two of the investigators. Standard variables for assessing diaphragm function will be used including diaphragmatic thickness, diaphragmatic thickness fraction, and diaphragmatic excursion (DE). 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 measure diaphragmatic thickness fraction, and diaphragmatic excursion [amplitude] respectively using both B and M modes.

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. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants who are born at ≤ 32 weeks gestation, admitted to the neonatal intensive care at Mount Sinai Hospital, and receiving oxygen or respiratory support at ≥ 36 weeks gestation will be eligible for the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the diaphragmatic Thickness fraction and diaphragmatic excursion in neonates with bronchopulmonary dysplasia
Time Frame: 1 year
  • Chest ultrasound will be used to evaluate the diaphragmatic function in neonates at ≥ 36 weeks gestation with bronchopulmonary dysplasia in comparison to diaphragmatic function in healthy newborns born at ≥ 36 weeks gestation.
  • Assessment of Diaphragmatic Thickness in millimetres.
  • Assessment of Diaphragmatic Excursion in millimetres.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mount Sinai Hospital, Canada

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-0224-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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