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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Daniele De Luca
Scientific

Service de Pédiatrie et Réanimation Néonatale
Hôpital "A.Béclère"
GHU Paris Saclay
157 rue de la Porte de Trivaux
Clamart
92140
France

ORCiD logoORCID ID 0000-0002-3846-4834
Phone +33145374837
Email dm.deluca@icloud.com

Study information

Study designObservational multicenter prospective pragmatic cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleLung ultrasound to follow evolution of chronic respiratory insufficiency and predict bronchopulmonary dysplasia in extremely preterm neonates: a multicenter, prospective, pragmatic, observational cohort study
Study acronymLUSTRE (Lung UltraSound To pReterm nEonates)
Study objectives1. 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) studiedChronic pulmonary insufficiency of prematurity (CPIP) and bronchopulmonary dysplasia (BPD)
InterventionLung 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 typeOther
Primary outcome measure1. 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 measuresNone
Overall study start date01/01/2017
Completion date01/09/2019

Eligibility

Participant type(s)Patient
Age groupNeonate
Lower age limit0 Days
SexBoth
Target number of participantsat least 100 (convenience sample size)
Total final enrolment147
Key inclusion criteriaInborn neonates with gestational age <=30+6 weeks
Key exclusion criteria1. 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 enrolment01/09/2017
Date of final enrolment30/06/2019

Locations

Countries of recruitment

  • France
  • Italy

Study participating centres

Paris Saclay University Hospital, "A.Béclère" Medical center
157 rue de la Porte de Trivaux
Clamart
92140
France
"G.Salesi" Women's and Children Hospital
via Filippo Corridoni 11
Ancona
60123
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Via della Commenda 12
Milano
20122
Italy
Policlinico Universitario di Padova
Via Niccolo Giustiniani 2
Padova
35128
Italy
AOU "Federico II"
via Sergio Pansini 5
Napoli
80131
Italy

Sponsor information

GHU Paris Saclay
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
Email alexandra.benachi@aphp.fr

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults 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 planThe 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.