Lung ultrasound score to predict the need of second dose of surfactant and respiratory outcomes in neonatal respiratory distress syndrome
| ISRCTN | ISRCTN88324348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88324348 |
| Secondary identifying numbers | 001 |
- Submission date
- 10/07/2025
- Registration date
- 19/09/2025
- Last edited
- 19/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims:
Newborn respiratory distress syndrome (NRDS) happens when a baby's lungs are not fully developed and cannot provide enough oxygen, causing breathing difficulties. NRDS usually occurs when the baby's lungs have not produced enough surfactant. Lung ultrasound score (LUS) calculated in the first 2 hours of life can reliably guide surfactant replacement in newborns with respiratory distress syndrome. This study explores the role of the early LUS in predicting the need for a second dose of surfactant.
Who can participate?
Premature newborns with respiratory distress, born between 25- 33 weeks of gestational age
What does the study involve?
Preterm newborns stabilized with respiratory distress according to the local NICU protocol with any kind of respiratory support were enrolled within 120 minutes of birth and LUS was calculated. Surfactant administration is decided by an attending neonatologist, unaware of the results of the LUS, based on radiographic and clinical signs.
The local investigator recorded the subsequent respiratory support provided and important clinical outcomes until discharge. The primary aim of the study is to evaluate the early LUS performance as a predictor of the second surfactant dose administration by an attending physician.
What are the possible benefits and risks of participating?
The possible benefit is to receive an early and individualized administration of the second surfactant dose before further deterioration of the newborn's clinical condition and potentially with better respiratory outcomes. No risks are expected because lung ultrasound is a non-invasive and radiation-free tool.
Where is the study run from?
University Federico II (Italy)
When is the study starting and how long is it expected to run for?
February 2022 to May 2025
Who is funding the study?
University Federico II (Italy)
Who is the main contact?
Prof. Francesco Raimondi, raimondi@unina.it
Contact information
Public, Scientific, Principal Investigator
via Pansini 5
Napoli
80131
Italy
 ORCID ID |
0000-0003-3250-1582 |
|---|---|
| Phone | + 39 (0)81 746 3004 |
| raimondi@unina.it |
Study information
| Study design | Observational prospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | An early lung ultrasound score predicts the need for surfactant retreatment and long-term outcomes in neonatal respiratory distress syndrome |
| Study acronym | LUSecond |
| Study objectives | To evaluate the lung ultrasound score (LUS) performance as a predictor of the second surfactant dose administration by a masked attending physician. An early LUS, done in the first 2 hours of life, will be considered. |
| Ethics approval(s) |
Approved 11/02/2022, Comitato Etico Universita Federico II (Pansini 5, Naples, 80131, Italy; +39 (0)81 7462596; segreteria@comitatoeticocampania3.it), ref: 386/21 |
| Health condition(s) or problem(s) studied | Neonatal respiratory distress syndrome |
| Intervention | Preterm neonates stabilized according to the local NICU protocol and managed with any kind of respiratory support are enrolled within 120 minutes of birth when important prenatal variables were recorded. During this time, the attending neonatologist, unaware of the purpose of the study, decides on the initial stabilization with either CPAP or nasal intermittent ventilation or mechanical ventilation according to the clinical condition. An investigator who was not involved in the clinical care records the respiratory support mode and level and oxygenation indices. The investigator also performed a lung ultrasound scan as previously described using three predefined ultrasound views (middle clavicular, anterior axillary and posterior axillary lines) on each side. |
| Intervention type | Other |
| Primary outcome measure | Early LUS performance as a predictor of the second surfactant dose administration by a masked attending physician. LUS is performed in the first 2 hours of life using the Brat score. |
| Secondary outcome measures | Main respiratory outcomes in relation to the need for a second surfactant dose, measured by evaluating oxygen indices and the respiratory technique used at stabilization. Bronchopulmonary dysplasia (according to the Jensen definition) and the number of deaths will be registered at discharge. |
| Overall study start date | 11/02/2022 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Days |
| Upper age limit | 1 Day |
| Sex | Both |
| Target number of participants | 225 |
| Total final enrolment | 225 |
| Key inclusion criteria | 1. Premature neonates with respiratory distress syndrome (RDS) 2. Born between 25- 33 weeks of gestational age calculated from the first day of the last menstrual period 3. Studied before their first surfactant dose |
| Key exclusion criteria | 1. Lack of parental consent 2. Major congenital malformations 3. Surfactant administration before lung ultrasound |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- Italy
Study participating centre
Napoli
80131
Italy
Sponsor information
University/education
via Pansini 5
Naples
80131
Italy
| Phone | +39 (0)81 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 | 01/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | PLanned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset of the current study will be available upon reasonable request to Prof. Francesco Raimondi (raimondi@unina.it) |
Editorial Notes
10/07/2025: Study's existence confirmed by the Comitato Etico Universita Federico II.
