Ultrasound Assessment of Diaphragmatic Function in Infants With BPD

NCT04941963 | Completed

• 1 other identifier: 19-0224-E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Bronchopulmonary Dysplasia

Keywords

preterm; neonates; Mechanical ventilation; Bronchopulmonary Dysplasia; Chest; Ultrasound

Outcome Measures

Primary Outcomes (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.

  1 year

Interventions

Chest ultrasound DIAGNOSTIC_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.

Eligibility Criteria

• Age: 36 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 35963296 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 28, 2021
• Study Start: November 26, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 15, 2022
• Last Updated: March 16, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)