Condition category
Neonatal Diseases
Date applied
05/05/2020
Date assigned
11/05/2020
Last edited
12/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daniele De Luca

ORCID ID

http://orcid.org/0000-0002-3846-4834

Contact details

Service de Pédiatrie et Réanimation Néonatale
Hôpital "A.Béclère"
GHU Paris Saclay
157 rue de la Porte de Trivaux
Clamart
92140
France
+33145374837
dm.deluca@icloud.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

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

Acronym

LUSTRE (Lung UltraSound To pReterm nEonates)

Study hypothesis

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

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

Study design

Observational multicenter prospective pragmatic cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

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 trial start date

01/01/2017

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inborn neonates with gestational age <=30+6 weeks

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

at least 100 (convenience sample size)

Participant 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

Recruitment start date

01/09/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

France, Italy

Trial participating centre

Paris Saclay University Hospital, "A.Béclère" Medical center
157 rue de la Porte de Trivaux
Clamart
92140
France

Trial participating centre

"G.Salesi" Women's and Children Hospital
via Filippo Corridoni 11
Ancona
60123
Italy

Trial participating centre

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Via della Commenda 12
Milano
20122
Italy

Trial participating centre

Policlinico Universitario di Padova
Via Niccolo Giustiniani 2
Padova
35128
Italy

Trial participating centre

AOU "Federico II"
via Sergio Pansini 5
Napoli
80131
Italy

Sponsor information

Organisation

GHU Paris Saclay

Sponsor details

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
‭+33 (0) 1 45 37 44 76
alexandra.benachi@aphp.fr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.