Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome
NCT ID: NCT04775459
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
84 participants
OBSERVATIONAL
2021-01-01
2021-05-31
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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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
Surfactant administration until 2020
Surfactant is administrated if Fi02 \>30% among the Guidelines of 2019
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
Surfactant administration since 2021
Surfactant is administrated if Fi02 \>30% OR if score LUS \>8/18 among the literature
Interventions
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Surfactant administration until 2020
Surfactant is administrated if Fi02 \>30% among the Guidelines of 2019
Surfactant administration since 2021
Surfactant is administrated if Fi02 \>30% OR if score LUS \>8/18 among the literature
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* born at the Saint Etienne University Hospital
* respiratory distress syndrome
Exclusion Criteria
* multi-polymalformations syndrome,
* congenital pulmonary disease,
* septic shock,
* congenital lung infection,
* meconium inhalation,
* pneumothorax
* conditions requiring surgery in the first week of life.
1 Day
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Aurelie CANTAIS, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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Chu de Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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IRBN232021/CHUSTE
Identifier Type: -
Identifier Source: org_study_id
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