Lung ultrasound score and variable respiratory support
| ISRCTN | ISRCTN10205806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10205806 |
| Secondary identifying numbers | 001 |
- Submission date
- 07/03/2025
- Registration date
- 16/06/2025
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Lung ultrasound predicts surfactant administration in neonates with moderate respiratory distress syndrome stabilized on continuous positive airway pressure (CPAP), but whether this is true for more critical infants is unknown. The objective of this study is to assess whether lung ultrasound may also predict surfactant replacement in infants on different respiratory support over a wide range of mean airway pressure.
Who can participate?
Neonates with respiratory distress in the first 2 hours of life stabilized with different techniques of respiratory support.
What does the study involve?
This study is a pragmatic, observational study set in Italian and Spanish neonatal intensive care units
What are the possible benefits and risks of participating?
It is hoped that future patients will benefit from the findings that lung ultrasound allows an early and targeted surfactant replacement.
Neonates participating in the study have no possible risks because they will not undergo new procedures because of the study itself. It is an observational study without interventions on patients.
Where is the study run from?
University of Naples Federico II (Italy). Neonatology Section
When is the study starting and how long is it expected to run for?
January 2022 to May 2025
Who is funding the study?
University of Naples Federico II (Italy)
Who is the main contact?
Prof Francesco Raimondi, raimondi@unina.it (Italy)
Contact information
Public, Scientific, Principal Investigator
University of Naples Federico II
Via Pansini 5
Napoli
80131
Italy
 ORCID ID |
0000-0003-3250-1582 |
|---|---|
| Phone | + 39 081 746 3004 |
| raimondi@unina.it |
Study information
| Study design | Observational prospective multicenter international cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a partecipant information sheet |
| Scientific title | Does lung ultrasound predict surfactant administration in neonates with respiratory distress stabilized with different support techniques? An international, pragmatic study |
| Study acronym | LUSVENT |
| Study objectives | Lung ultrasound accurately predicts surfactant administration in neonates with respiratory distress syndrome stabilized on CPAP. However, whether this is true for more critical infants stabilized with non-invasive or invasive ventilation is unknown. The objective of the study is to assess whether lung ultrasound may also predict surfactant replacement in infants on different respiratory support over a wide range of mean airway pressure |
| Ethics approval(s) |
Approved 11/02/2022, Comitato Etico Universita’ Federico II (Via Pansini 5, Napoli, 80131, Italy; +39 081 746 2596; segreteria@comitatoeticocampania3.it), ref: 386/21 |
| Health condition(s) or problem(s) studied | Accuracy of lung ultrasound score to predict surfactant administration in neonates with respiratory distress stabilized with different support techniques |
| Intervention | The lung ultrasound score will be obtained for three groups of neonates with respiratory distress, stabilized on continuous positive airway pressure (CPAP), non-invasive ventilation and invasive ventilation within 2 hours of life. The result of the score will be carefully concealed from the attending physician evaluating the later need for surfactant administration. The predictive accuracy for surfactant of the lung ultrasound score alone or with non-invasive variables will be investigated according to the different respiratory support techniques. After the lung ultrasound at the enrolment, participants will receive a lung ultrasound at 7 days of life and 36 weeks of gestational age. Data relating to general prenatal and neonatal characteristics, respiratory support, oxygen supplementation, onset of complications of prematurity will be monitored and collected until discharge from NICU. |
| Intervention type | Other |
| Primary outcome measure | The predictive accuracy of the lung ultrasound score of surfactant therapy measured using the Brat Score in the first 2 hours of life |
| Secondary outcome measures | 1. The prognostic accuracy for surfactant administration measured using data collected from patient medical record in the whole population and the three groups of the following individual predictors at enrolment, 7 days and 36 weeks of gestational age: 1.1. SatO2/ FiO2 1.2. FiO2>0.3 1.3. OSI index 2. The prognostic accuracy for surfactant administration in the whole population of a previously developed logistic regression model based on lung ultrasound according to the Brat Score, gestational age, with/without oxygenation indexes evaluated at the enrolment. 3. The clinical trajectory and outcome of infants stabilized with techniques other than CPAP evaluating the progression of lung ultrasound score and oxygenation indexes at enrolment, 7 days and 36 weeks of gestational age and evaluating need and duration of oxygen and respiratory support, diagnosis of bronchopulmonary dysplasia and death at the end of NICU staying. |
| Overall study start date | 07/01/2022 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 1 Day |
| Upper age limit | 1 Day |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | 1. Premature neonates with respiratory distress 3. Any gestational age 2. Enrolled within 2 hours of birth 3. Before the administration of the first surfactant dose |
| Key exclusion criteria | 1. Infants with major congenital malformations 2. Those who had already been given surfactant |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 01/05/2025 |
Locations
Countries of recruitment
- Italy
- Spain
Study participating centres
Napoli
80131
Italy
Cadiz
11009
Spain
Milano
20162
Italy
Badalona
08916
Spain
Madrid
28009
Spain
milano
20154
Italy
Padova
35128
Italy
Roma
00136
Italy
Sponsor information
University/education
Neonatologia
via Pansini 5
Naples
80131
Italy
| Phone | +39 081 7463268 |
|---|---|
| dip.scienze-medtras@unina.it | |
| Website | https://www.unina.it |
"ROR" |
https://ror.org/05290cv24 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Naples Federico II, University of Naples, Federico II University of Naples, Università di Napoli, Università di Napoli Federico II, UNINA
- Location
- Italy
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned pubblications in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Francesco Raimondi, raimondi@unina.it (Italy) from May 2026. • The type of data that will be shared: all data registered in the Excel database of the study • Timing for availability: 5 years from publication of study • Whether consent from participants was required and obtained: consent required and obtained (study in progress) • Comments on data anonymization: data will be shared completely anonymised • Any ethical or legal restrictions: no restriction • Any additional comments: Data will be available upon reasonable request |
Editorial Notes
10/03/2025: Ethics Committee of the Federico II University (Comitato Etico Universita’ Federico II)
