Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia

NCT04756297 | Completed

• 1 other identifier: 19-0072-E
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

Extreme preterm infants (GA ≤ 28+6 weeks) are at high risk for bronchopulmonary dysplasia (BPD) that has been associated with significant long-term impairment. Lung ultrasound score (LUSs) has the potential to early identify infants at high risk of developing BPD who may benefit from early intervention. Aim: To assess if LUS score can be utilized to predict the development of BPD in infants born at ≤ 28+6 weeks, early in their postnatal course, when the disease is likely to be most amenable to therapeutic intervention.

Conditions

Bronchopulmonary Dysplasia (BPD)

Outcome Measures

Primary Outcomes (1)

• Assess accuracy of LUSs for early identification of BPD in extreme preterm infants

  The primary outcome of this study is to assess predictive characteristics of LUS score: Sensitivity, specificity, positive and negative predictive value, likelihood ratio and c-statistics of LUS score. Assessment of BPD at 36 weeks will be done as per currently used standard criteria for BPD. The primary outcome of this study is to assess predictive characteristics of LUS score: Sensitivity, specificity, positive and negative predictive value, likelihood ratio and c-statistics of LUS score. Assessment of BPD at 36 weeks will be done as per currently used standard criteria for BPD. LUS will be conducted at D3, 7 and 14 of life

  2 weeks after birth

Secondary Outcomes (1)

• Assess predictive characteristics of LUS score integration in clinical variables derived model to see which model has higher predictive characteristics

  2 WEEKS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All infants who are born at GA ≤ 28+6 weeks will be enrolled in the study after obtaining REB approval and parents' consent.

You may qualify if:

• GA ≤ 28+6 weeks Admitted to the NICU at Mount Sinai Hospital or Health sciences Centre-Winnipeg consent obtained.

You may not qualify if:

• Infants who are born at \> 28 weeks GA, or have congenital or chromosomal abnormalities, or parents declined consent will be excluded.

Sponsors & Collaborators

• Adel Mohamed: lead
• Mount Sinai Hospital, Canada: collaborator
• Health Sciences Centre, Winnipeg, Manitoba: collaborator

Study Sites (2)

Health Sciences Centre

Winnipeg, Manitoba, R3C3H8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Mohamed A, Mohsen N, Diambomba Y, Lashin A, Louis D, Elsayed Y, Shah PS. Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia in Extreme Preterm Neonates: A Prospective Diagnostic Cohort Study. J Pediatr. 2021 Nov;238:187-192.e2. doi: 10.1016/j.jpeds.2021.06.079. Epub 2021 Jul 6.

  PMID: 34237347 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

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

Study Officials

• Prakesh Shah, MD

  Mount Sinai Hospital- Toronto, ON, Canada

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Paediarics

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: July 1, 2019
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CA (2)