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Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04775459
Acronym
ECHOSURF
Enrollment
84
Registered
2021-03-01
Start date
2021-01-01
Completion date
2021-05-31
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Preterm, Lung Ultrasound Score, Surfactant

Brief 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. 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).

Interventions

DRUGSurfactant administration until 2020

Surfactant is administrated if Fi02 \>30% among the Guidelines of 2019

DRUGSurfactant administration since 2021

Surfactant is administrated if Fi02 \>30% OR if score LUS \>8/18 among the literature

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No

Inclusion criteria

* newborns \<33 weeks old * born at the Saint Etienne University Hospital * respiratory distress syndrome

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
administration time frame (min of life)day 1Time from birth to surfactant administration

Secondary

MeasureTime frameDescription
FiO2 maximumWeek 1Collect in medical record.: the maximal value of FiO2 from birth to one week of life
delay from FiO2 maximum to FiO2 < 21%Week 4Collect in medical record
Ventilation time (day)Week 4Collect in medical record : number of day using a ventilation
Ventilation supportWeek 4Collect in medical record : using a invasive ou a non invasive ventilation
Bronchodysplasia rateWeek 4Collect in medical record.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026