Lung ultrasound to monitor respiratory function in extremely preterm neonates
| ISRCTN | ISRCTN16987738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16987738 |
- Submission date
- 05/05/2020
- Registration date
- 11/05/2020
- Last edited
- 27/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Lung ultrasound is a radiation-free, non-invasive and simple technique commonly used in critical care medicine. The use of lung ultrasound is associated with many advantages in patients with acute respiratory failure and does not present any safety risk, unlike X-rays. Thus, these characteristics identify lung ultrasound as a suitable technique to follow-up preterm neonates. In fact, these small patients are hospitalized for several weeks needing some types of respiratory support while they grow up. This situation is called “chronic respiratory insufficiency of prematurity”, may last for long time and may evolve into bronchopulmonary dysplasia (BPD). This latter is a chronic prematurity-related disease which is diagnosed at 36 weeks post-menstrual age, that is, several weeks after the birth of an extremely preterm infant. BPD represents an important clinical outcome but is only diagnosed according to some clinical criteria (such as need for oxygen or other respiratory support) accumulated overtime (after the first days of life until the 36 weeks’ time-point). To date there is no diagnostic tool available to diagnose BPD.
Lung ultrasound holds the potential to be a simple, non-invasive and useful tool: 1) to monitor how neonates are doing, and 2) to eventually predict the BPD occurrence. The main study aim is to verify that lung ultrasound can successfully achieve these two results.
Who can participate?
Neonates with gestational age <=30+6 weeks
What does the study involve?
Extremely preterm neonates fulfilling inclusion criteria will be included and will receive a lung ultrasound examination every 7-14 days during their hospitalization. The images obtained will be used to understand the respiratory function and eventually predict the occurrence of BPD. The images will be recorded together with some basic data usually registered in patients’ files (amount of oxygen, type of respiratory support) and demographics.
What are the possible benefits and risks of participating?
This study is totally free of risk for recruited patients, since lung ultrasound is a non-invasive technique, only requiring few minutes, and already used in clinical care. Conversely, the study will be useful for many patients worldwide if the usefulness of lung ultrasound, in respect to the two main study aims, will be demonstrated: this will help diffusing the technique and improving the care of preterm infants worldwide.
Where is the study run from?
Paris Saclay University Hospital, "A.Béclère" Medical center (France)
When is the study starting and how long is it expected to run for?
January 2017 to September 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Daniele De Luca, dm.deluca@icloud.com
Contact information
Scientific
Service de Pédiatrie et Réanimation Néonatale
Hôpital "A.Béclère"
GHU Paris Saclay
157 rue de la Porte de Trivaux
Clamart
92140
France
 ORCID ID |
0000-0002-3846-4834 |
|---|---|
| Phone | +33145374837 |
| dm.deluca@icloud.com |
Study information
| Study design | Observational multicenter prospective pragmatic 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 to follow evolution of chronic respiratory insufficiency and predict bronchopulmonary dysplasia in extremely preterm neonates: a multicenter, prospective, pragmatic, observational cohort study |
| Study acronym | LUSTRE (Lung UltraSound To pReterm nEonates) |
| Study objectives | 1. Semi-quantitative lung ultrasound through the calculation of lung ultrasound scores is useful to monitor respiratory function in neonates with chronic pulmonary insufficiency of prematurity (CPIP). 2. Semi-quantitative lung ultrasound through the calculation of lung ultrasound scores is useful to predict bronchopulmonary dysplasia (BPD) occurrence. |
| Ethics approval(s) | Approved 10/03/2017, Commission d'Ethique de la Société de Reanimation de Langue Francaise (48, avenue Claude Vellefaux – 75010 Paris, France; +33 (0)1 45 86 74 00; secretariat@srlf.org), ref: SRLF16-58 |
| Health condition(s) or problem(s) studied | Chronic pulmonary insufficiency of prematurity (CPIP) and bronchopulmonary dysplasia (BPD) |
| Intervention | Lung ultrasound performed serially every 7 - 14 days in extremely preterm neonates with CPIP and hospitalised in neonatal intensive care units. Based on lung ultrasound findings a lung ultrasound score will be calculated as published by Brat R. JAMA Pediatr 2015. An extended lung ultrasound score will also be calculated considering ultrasound findings in posterior lung zones. |
| Intervention type | Other |
| Primary outcome measure | 1. Lung aeration in neonates with CPIP using the correlation between lung ultrasound scores (calculated as published by Brat R. JAMA Pediatr 2015) and gas exchange measures performed every 7 - 14 days 2. Bronchopulmonary dysplasia (BPD) at 36 weeks post-menstrual age measured according to clinical criteria (such as need for oxygen or other respiratory support) |
| Secondary outcome measures | None |
| Overall study start date | 01/01/2017 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Days |
| Sex | Both |
| Target number of participants | at least 100 (convenience sample size) |
| Total final enrolment | 147 |
| Key inclusion criteria | Inborn neonates with gestational age <=30+6 weeks |
| Key exclusion criteria | 1. Complex congenital malformations 2. Chromosomal abnormalities 3. Pulmonary hypoplasia 4. Congenital anomalies of surfactant proteins or any other suspected congenital lung disorders |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- France
- Italy
Study participating centres
Clamart
92140
France
Ancona
60123
Italy
Milano
20122
Italy
Padova
35128
Italy
Napoli
80131
Italy
Sponsor information
Hospital/treatment centre
Prof. Alexandra Benachi, Directrice du DMU
DMU Santé Femme et Nouveau-né
Hopital "A.Béclère"
157 rue de la Porte de Trivaux
Clamart
92140
France
| Phone | +33 (0) 1 45 37 44 76 |
|---|---|
| alexandra.benachi@aphp.fr |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be partially presented at Pediatric Academic Society Meeting in the US and at the meeting of the European Society for Pediatric and Neonatal Intensive Care (ESPNIC) in Europe.. Then results will be published in one or more article(s). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 11/05/2020 | 12/05/2020 | No | No | |
| Results article | 01/06/2021 | 27/12/2023 | Yes | No |
Additional files
- ISRCTN16987738_PROTOCOL_11May2020.pdf
- uploaded 12/05/2020
Editorial Notes
27/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
12/05/2020: Uploaded protocol (not peer reviewed) as an additional file.
11/05/2020: Trial’s existence confirmed by Commission d'Ethique de la Société de Reanimation de Langue Francaise.
