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OpenTrials
Completed

NCT Number: NCT04775459

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

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).

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surfactant administration until 2020

Drug

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

Other names: No LUS

Surfactant administration since 2021

Drug

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

Other names: With LUS

Primary outcomes

  1. administration time frame (min of life)

    Time frame: day 1

    Time from birth to surfactant administration

Secondary outcomes

  1. FiO2 maximum

    Time frame: Week 1

    Collect in medical record.: the maximal value of FiO2 from birth to one week of life

  2. delay from FiO2 maximum to FiO2 < 21%

    Time frame: Week 4

    Collect in medical record

  3. Ventilation time (day)

    Time frame: Week 4

    Collect in medical record : number of day using a ventilation

  4. Ventilation support

    Time frame: Week 4

    Collect in medical record : using a invasive ou a non invasive ventilation

  5. Bronchodysplasia rate

    Time frame: Week 4

    Collect in medical record.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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.

Acronym: ECHOSURF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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