A study about the relationship between lung ultrasound findings and inflammatory markers in neonates with respiratory failure
| ISRCTN | ISRCTN13964911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13964911 |
- Submission date
- 02/10/2021
- Registration date
- 05/10/2021
- Last edited
- 01/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Ultrasound is a non-invasive technique that uses a device placed against the skin to emit and receive high-frequency sound waves to create an image of part of the inside of the body, for example, to monitor developments during pregnancy. Lung ultrasound is a useful medical technique that can be used to evaluate the appearance and function of the lungs. This is needed for newborns with breathing (respiratory) difficulties. In these newborns, consolidations may be seen on ultrasound. These are areas of the lungs that should be filled with air but are instead filled with a liquid or a solid.
The aim of this study is to demonstrate that the size and/or number of consolidations in newborns with respiratory failure are related to the patients' inflammatory status. Inflammatory marker levels will be raised during infection and are commonly measured in routine clinical care of newborns. There are many causes for newborns to develop respiratory failure and it is important to be able to make a correct diagnosis in order to treat them in the appropriate way. It is hoped that this study will help doctors to decide whether the cause of respiratory failure is an infection or not.
Who can participate?
Newborns (aged 0-4 weeks) admitted to a neonatal intensive care unit with any type of respiratory failure and having consolidations at the lung ultrasound.
What does the study involve?
The study involves a lung ultrasound scan of the newborn. This is a non-invasive diagnostic procedure that is already performed within routine care in the participating centres. The study also involves the collection of clinical data and the value of inflammatory markers that will be measured during routine care.
What are the possible benefits and risks of participating?
It is hoped that the results of this study will allow us to better understand and interpret ultrasound signs, therefore allowing doctors to confirm whether respiratory failure in newborns has been caused by an infection. This will help to provide a more accurate diagnosis and to provide fast and effective care.
There are no risks associated with this study. There will be no intervention beyond routine clinical care and there will only be a simple data collection during this care. Participants in the study will not receive any changes to their treatment. Collected data will be totally anonymous and the study will respect all relevant privacy regulations. Good clinical research practices will always be respected.
Where is the study run from?
Neonatal Intensive Care Units in France, Italy, and Spain with particular expertise in lung ultrasound using this technique within their common routine clinical care.
When is the study starting and how long is it expected to run for?
From January 2021 to December 2022
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Prof. Daniele De Luca
daniele.deluca@aphp.fr
Contact information
Public, Scientific
Division of Pediatrics and Neonatal Critical Care
Paris Saclay University Hospitals
"A. Beclere" Medical Center
157 rue de la Porte de Trivaux
Clamart
Paris
92140
France
 ORCID ID |
0000-0002-3846-4834 |
|---|---|
| Phone | +33145374837 |
| daniele.deluca@aphp.fr |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Lung ultrasound features and inflammation in NICU-admitted neonates (UNION) |
| Study acronym | UNION |
| Study objectives | Size or aspects of consolidations at the lung ultrasound may help to distinguish their infectious or non-infectious origin. |
| Ethics approval(s) | Approved 04/04/2021, Critical Care French Ethical Commission (SRLF Commission d'Ethique, 48, avenue Claude Vellefaux, 75010 Paris; +33 (0)1 45 86 74 00; secretariat@srlf.org), ref: 21/33 |
| Health condition(s) or problem(s) studied | Refined diagnosis of different types of neonatal respiratory failure |
| Intervention | 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, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2018 Jul 20:1–8. doi: 10.1038/s41390-018-0114-9. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2021 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 160 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/04/2021 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- France
- Italy
- Spain
Study participating centres
Clamart
Paris
92140
France
Via Della Commenda 12
Milano
20122
Italy
Via Sergio Pansini
Napoli
80131
Italy
Via Nicolò Giustiniani 2
Padova
35128
Italy
Avenida Ana de Viya 21
Cadiz
11009
Spain
Sponsor information
Hospital/treatment centre
APHP- Departement Medico-Universitaire n.2 "Santé des Femmes et Nouveau-nés"
157 rue de la Porte de Trivaux
Clamnart (Paris)
92140
France
| Phone | +145374476 |
|---|---|
| alxandra.benachi@aphp.fr | |
| Website | http://www.aphp.fr/contenu/hopital-antoine-beclere-1 |
"ROR" |
https://ror.org/04sb8a726 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study results will be presented at the main international congress in the field of neonatal critical care (for ex.: ESPNIC, PAS) and published in one or more articles in top flag journals. ICMJE criteria for authorship and STROBE guidelines will be applied. |
| IPD sharing plan | The anonymous dataset generated and analysed during the study will be available upon reasonable request from the PI Prof. Daniele De Luca (daniele.deluca@aphp.fr). Availability may be subject to administrative approval according to privacy regulations, depending on the country from which the request originates. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/02/2024 | 29/02/2024 | Yes | No |
Editorial Notes
29/02/2024: Publication reference added.
05/10/2021: Trial’s existence confirmed by Société de Réanimation de Langue Française.
