Assessing the likelihood of needing a substance called surfactant for newborns born near their expected delivery date using lung ultrasound
| ISRCTN | ISRCTN18610513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18610513 |
- Submission date
- 23/12/2023
- Registration date
- 02/01/2024
- Last edited
- 14/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Lung ultrasound is a non-invasive, easy and quick technique that is being increasingly used in the clinical practice worldwide. It has been proven to be very accurate to evaluate the severity of respiratory failure and the need for surfactant replacement in preterm and extremely preterm neonates. Nonetheless, it is unclear if it is equally accurate and useful to predict surfactant need in late preterm and term neonates, as they may be affected by different types of respiratory failure.
Who can participate?
Late preterm and term (i.e. beyond 34 weeks' gestation) may be enrolled in this study
What does the study involve?
The study is performed within the usual routine care in the participating centres. The results of lung ultrasound will be collected together with the data registered during the standard monitoring of these patients.
What are the possible benefits and risks of participating?
Participation in the study will be useful and bring benefits on a larger scale since it may significantly improve the management of these patients.
No test is performed solely for study purposes and and there is no risk whatsoever for the patients. On the contrary, lung ultrasound is non-invasive and is already used in clinical practice to visualise the lungs and have more insights about the respiratory disorder.
Where is the study run from?
APHP-Paris Saclay University DMU2 (France)
Universita degli Studi di Padova (Italy)-Dpt di Pediatria
NICU, Hospital Universitario “Puerta del Mar” Cadiz (Spain)
NICU, Dept of Pediatrics, Stanford University (Palo Alto-CA, USA)
NICU, Federico II University Napoli (Italy)
When is the study starting and how long is it expected to run for?
June 2021 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Daniele De Luca (MD, PhD), daniele.deluca@aphp.fr
Contact information
Public, Scientific, Principal Investigator
Hospital A.Beclere
Clamart
92140
France
 ORCID ID |
0000-0002-3846-4834 |
|---|---|
| Phone | +33 145374837 |
| daniele.deluca@aphp.fr |
Study information
| Study design | Prospective observational pragmatic non-invasive international multi-center cohort 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 patient information sheet. |
| Scientific title | Quantitative lung ultrasound to predict surfactant need in late preterm and term neonates with respiratory failure |
| Study acronym | ULTRAS |
| Study objectives | A previously validated and well known neonatal lung ultrasound score can predict the surfactant need in late preterm and term neonates with respiratory failure in the first 72h of life with at least the same accuracy shown in preterm neonates. |
| Ethics approval(s) |
Approved 30/06/2022, Comitato Etico per la Sperimentazione Clinica della Provincia di Padova (via Giustiniani 1, Padova, 35128, Italy; +39 498211435; luca.bonadies@unipd.it), ref: 5495/AO/22 |
| Health condition(s) or problem(s) studied | Surfactant need in late preterm and term infants |
| Intervention | Calculation of the lung ultrasound scores performed upon NICU admission and before surfactant administration (if any) together with the consideration of data issued of vital monitoring. Ultrasound and monitoring are performed within the routine clinical care in the participating centers (so that no test is performed solely for study purposes) and the study is pragmatically "nested" within clinical care. |
| Intervention type | Other |
| Primary outcome measure | Upon NICU admission and before surfactant administration (if any): 1. Diagnostic accuracy measures (area under the ROC curve and derived accuracy variables). For these outcomes, lung ultrasound scores and need for surfactant replacement will be collected (i.e.: this will allow the raw calculation of true and false positives and negatives). 2. Additionally demographics, clinical and monitoring variables usually registered during routine care will be collected. |
| Secondary outcome measures | Oxygenation metrics measured with usual vital monitoring available in each center and its relationship with lung ultrasound score measured using patient records upon NICU admission and before surfactant administration (if any) |
| Overall study start date | 01/06/2021 |
| Completion date | 20/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 142 |
| Total final enrolment | 157 |
| Key inclusion criteria | All late preterm and term (>=34 weeks' gestation) neonates admitted to the NICU in the first 72 h of life with respiratory failure |
| Key exclusion criteria | 1. Major congenital malformations or chromosomopathies 2. Airleaks preventing a comprehensive lung ultrasound examination 3. Early onset sepsis and hemodynamic instability (defined as need for any inotrope) 4. Congenital surfactant anomalies 5. Pulmonary hypoplasia or congenital lung malformations 6. PPHN 7. Need for surgery in the first week of life |
| Date of first enrolment | 01/12/2022 |
| Date of final enrolment | 20/12/2023 |
Locations
Countries of recruitment
- France
- Italy
- Spain
- United States of America
Study participating centres
Clamart
92140
France
Padova
35128
Italy
Napoli
80131
Italy
Cadiz
11009
Spain
Palo Alto (CA)
94304
United States of America
Sponsor information
Hospital/treatment centre
157 rue de la Porte de Trivaux
Clamart (Paris)
92140
France
| Phone | +33 145374837 |
|---|---|
| alexandra.benachi@aphp.fr |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact journals and partial data presentation at the main North-America and European NICU congresses |
| IPD sharing plan | The whole dataset used in the study will be available from the study coordinator (Prof. Daniele De Luca (MD, PhD) - daniele.deluca@aphp.fr) upon reasonable request with clear aims and respecting privacy regulation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 28/12/2023 | No | No | ||
| Results article | 01/05/2024 | 14/06/2024 | Yes | No |
Additional files
Editorial Notes
14/06/2024: Publication reference added.
28/12/2023: Trial's existence confirmed by Comitato Etico per la Sperimentazione Clinica della Provincia di Padova.
