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

Lung ultrasound features and inflammation in NICU-admitted neonates (UNION)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13964911

Enrollment

160

Registered

2021-10-05

Start date

2021-04-15

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refined diagnosis of different types of neonatal respiratory failure Pregnancy and Childbirth Respiratory failure of newborn

Interventions

Point-of-care lung ultrasound at the bedside will be performed within the routine clinical care of the neonate. Details of the technique are available in Raimondi F, Yousef N, Migliaro F, Capasso L, D

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

France, Italy, Spain

Contacts

Public ContactDaniele De Luca

daniele.deluca@aphp.fr+33145374837

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026