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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Preterm Birth

Treatments

Drug: Surfactant administration since 2021
Drug: Surfactant administration until 2020

Study type

Observational

Funder types

Other

Identifiers

NCT04775459
IRBN232021/CHUSTE

Details and patient eligibility

About

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).

Full 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).

Enrollment

84 patients

Sex

All

Ages

Under 1 day old

Volunteers

No Healthy Volunteers

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.

Trial design

84 participants in 2 patient groups

Surfactant administration without using score LUS
Description:
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
Treatment:
Drug: Surfactant administration until 2020
Surfactant administration using score LUS
Description:
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
Treatment:
Drug: Surfactant administration since 2021

Trial contacts and locations

1

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Central trial contact

Aurelie CANTAIS, MD; Hugues PATURAL, MD PhD

Data sourced from clinicaltrials.gov

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