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Bronchopulmonary DysplasiaNCT04941963

Ultrasound Assessment of Diaphragmatic Function in Infants With BPD

An observational study of Bronchopulmonary Dysplasia, run by Mount Sinai Hospital, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preterm infants have high and prolonged exposure to positive pressure ventilation, which contributes to acute lung injury and the development of bronchopulmonary dysplasia (BPD). Read more about this study

Who is it for?
Ages 36 weeks and older
Conditions the study is for
Bronchopulmonary Dysplasia
What is being tested?
Chest ultrasound
How many people
100 participants
Where
1 siteCanada
Study dates
26 Nov 2019to 15 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Infants who have congenital or chromosomal abnormalities.
  • Parents declined the consent.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Chest ultrasound
Keywords
preterm, neonates, Mechanical ventilation, Bronchopulmonary Dysplasia, Chest, Ultrasound
Medical subject headings
Bronchopulmonary Dysplasia, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest ultrasoundDiagnostic test

    Patients will undergo chest ultrasound scanning after obtaining parent's consent. each enrolled patient will have one chest ultrasound to assess diaphragmatic function and lung ultrasound severity score.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    • 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start26 Nov 2019
  3. Primary completion1 Jul 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941963
Sponsor's protocol ID
19-0224-E
Status last verified
Oct 2021
First submitted
20 May 2021
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yeung T, Mohsen N, Ghanem M, Ibrahim J, Shah J, Kajal D, Shah PS, Mohamed A. Diaphragmatic Thickness and Excursion in Preterm Infants With Bronchopulmonary Dysplasia Compared With Term or Near Term Infants: A Prospective Observational Study. Chest. 2023 Feb;163(2):324-331. doi: 10.1016/j.chest.2022.08.003. Epub 2022 Aug 10.

    PubMed 35963296

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchopulmonary Dysplasia, run by Mount Sinai Hospital, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the diaphragmatic Thickness fraction and diaphragmatic excursion in neonates with bronchopulmonary dysplasia (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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