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

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).

Study Overview

• Status: Unknown
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: Surfactant administration until 2020; Drug: Surfactant administration since 2021

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Aurelie CANTAIS, MD; Phone Number: +33 (0)477829295; Email: aurelie.cantais@chu-st-etienne.fr
• Study Contact Backup: Name: Hugues PATURAL, MD PhD; Email: hughes.patural@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de SAINT-ETIENNE
    • Contact: Aurelie CANTAIS, MD; Phone Number: +33 (0)477829295; Email: aurelie.cantais@chu-st-etienne.fr
    • Principal Investigator: Aurelie CANTAIS, MD
    • Sub-Investigator: Hughes PATURAL, MD PhD
    • Sub-Investigator: Marion TOURNAYRE, resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Surfactant administration until 2020; Surfactant is administrated if Fi02 >30% among the Guidelines of 2019; Other Names: No LUS
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	Drug: Surfactant administration since 2021; Surfactant is administrated if Fi02 >30% OR if score LUS >8/18 among the literature; Other Names: With LUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
administration time frame (min of life)	Time from birth to surfactant administration	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FiO2 maximum	Collect in medical record.: the maximal value of FiO2 from birth to one week of life	Week 1
delay from FiO2 maximum to FiO2 < 21%	Collect in medical record	Week 4
Ventilation time (day)	Collect in medical record : number of day using a ventilation	Week 4
Ventilation support	Collect in medical record : using a invasive ou a non invasive ventilation	Week 4
Bronchodysplasia rate	Collect in medical record.	Week 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Aurelie CANTAIS, MD, CHU de SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Surfactant; Preterm; Lung Ultrasound Score
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: IRBN232021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No