Preterm BirthECHOSURFNCT04775459
Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome
An observational study of Preterm Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP). This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Surfactant administration until 2020 and Surfactant administration since 2021
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: preterm newborns < 33 weeks with Respiratory Distress Syndrom needed surfactant administration Date of birth from 01/08/19 to 31/12/19 and from 01/01/21 to 30/06/21
Who may be able to join
- newborns <33 weeks old
- born at the Saint Etienne University Hospital
- respiratory distress syndrome
Who cannot join
- chromosomal abnormality,
- multi-polymalformations syndrome,
- congenital pulmonary disease,
- septic shock,
- congenital lung infection,
- meconium inhalation,
- pneumothorax
- conditions requiring surgery in the first week of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.
Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).
This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.
Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).
Read the detailed description
This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms <33 weeks on the time to surfactant administration.
The current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life.
This is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).
- Conditions
- Preterm Birth
- Being tested
- Surfactant administration until 2020, Surfactant administration since 2021
- Keywords
- Preterm, Lung Ultrasound Score, Surfactant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant administration until 2020Drug
Also called No LUS
Surfactant is administrated if Fi02 >30% among the Guidelines of 2019
Surfactant administration since 2021Drug
Also called With LUS
Surfactant is administrated if Fi02 >30% OR if score LUS >8/18 among the literature
| Study group | Role | What they receive |
|---|---|---|
| Surfactant administration without using score LUS | It is a retrospective cohort : preterm newborns from august 2019 to december 2019 needed a surfactant administration.
The surfactant was administrated only if the fraction of inspired oxygen (FiO2) >30% among the Guidelines of 2019 Receives: Drug: Surfactant administration until 2020 | |
| Surfactant administration using score LUS | It is a prospective cohort : preterm newborns from january 2021 to juin 2020 needed a surfactant administration.
The surfactant is administrated if FiO2 >30% OR if score LUS >8/18 among the literature Receives: Drug: Surfactant administration since 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
administration time frame (min of life)
Time from birth to surfactant administration
Measured: day 1
Secondary outcomes (5)
FiO2 maximum
Collect in medical record.: the maximal value of FiO2 from birth to one week of life
Measured: Week 1
delay from FiO2 maximum to FiO2 < 21%
Collect in medical record
Measured: Week 4
Ventilation time (day)
Collect in medical record : number of day using a ventilation
Measured: Week 4
Ventilation support
Collect in medical record : using a invasive ou a non invasive ventilation
Measured: Week 4
Bronchodysplasia rate
Collect in medical record.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelie CANTAIS, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775459
- Sponsor's protocol ID
- IRBN232021/CHUSTE
- Acronym
- ECHOSURF
- Status last verified
- Jun 2024
- First submitted
- 25 Feb 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.
- ClinicalTrials.gov ID
- NCT04775459
- Acronym / sponsor ID
- ECHOSURF / IRBN232021/CHUSTE
- Conditions
- Preterm Birth
- Keywords
- Preterm, Lung Ultrasound Score, Surfactant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).
This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.
Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).
Detailed description
This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms <33 weeks on the time to surfactant administration.
The current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life.
This is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant administration without using score LUS | – | Drug: Surfactant administration until 2020It is a retrospective cohort : preterm newborns from august 2019 to december 2019 needed a surfactant administration. The surfactant was administrated only if the fraction of inspired oxygen (FiO2) >30% among the Guidelines of 2019 |
| Surfactant administration using score LUS | – | Drug: Surfactant administration since 2021It is a prospective cohort : preterm newborns from january 2021 to juin 2020 needed a surfactant administration. The surfactant is administrated if FiO2 >30% OR if score LUS >8/18 among the literature |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm newborns < 33 weeks with Respiratory Distress Syndrom needed surfactant administration Date of birth from 01/08/19 to 31/12/19 and from 01/01/21 to 30/06/21
Key inclusion criteria (3 listed)
- newborns <33 weeks old
- born at the Saint Etienne University Hospital
- respiratory distress syndrome
Key exclusion criteria (8 listed)
- chromosomal abnormality,
- multi-polymalformations syndrome,
- congenital pulmonary disease,
- septic shock,
- congenital lung infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surfactant administration until 2020Also: No LUSSurfactant is administrated if Fi02 >30% among the Guidelines of 2019 | Drug | Surfactant administration without using score LUS |
| Surfactant administration since 2021Also: With LUSSurfactant is administrated if Fi02 >30% OR if score LUS >8/18 among the literature | Drug | Surfactant administration using score LUS |
Primary outcome
administration time frame (min of life)
Time frame: day 1
Time from birth to surfactant administration
5 secondary outcomes
FiO2 maximum
Time frame: Week 1
delay from FiO2 maximum to FiO2 < 21%
Time frame: Week 4
Ventilation time (day)
Time frame: Week 4
Ventilation support
Time frame: Week 4
Bronchodysplasia rate
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelie CANTAIS, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
administration time frame (min of life) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.