A study about the relationship between lung ultrasound findings and inflammatory markers in neonates with respiratory failure

Not Applicable

Completed

• Conditions: Refined diagnosis of different types of neonatal respiratory failure; Pregnancy and Childbirth; Respiratory failure of newborn

• Registration Number: ISRCTN13964911
• Lead Sponsor: Hôpital Antoine-Béclère

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38367957/ (added 29/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Study Completion: 2022-12-31
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Neonates presenting with respiratory failure
2. Requiring any type of respiratory support including O2 supplementation, HHHFNC, CPAP, different types of NIV or invasive ventilation, or ECMO
3. =1 consolidation on lung ultrasound performed during clinical care. Consolidation is defined according to classical lung ultrasound semiology as the presence of echo-poor or tissue-like echotexture originating from the pleural line area with irregular borders, which may also have mixed hypoechogenic and hyperechogenic spots representing air bronchograms. In order to search for consolidations, a lung ultrasound exam must be complete and all chest areas (including posterior ones) should be scanned.

Exclusion Criteria

1. Major congenital malformations
2. Congenital lung anomalies
3. Cytogenetic anomalies
4. Need for thoracic surgery
5. Massive air leaks preventing a detailed evaluation of lung parenchyma

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Integrated clinical diagnosis obtained using clinical and anamnestic data, together with following, collected within routine care: <br>1. Lung ultrasound score calculated using point-of-care lung ultrasound <br>2. Maximal size from the pleura to their inferior margin of consolidation measured using point-of-care lung ultrasound<br>3. Inflammatory biomarker (such as procalcitonin, C-reactive protein, or others) levels measured using clinical routine blood samples

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures