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

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Surfactant administration until 2020; Drug: Surfactant administration since 2021

• Registration Number: NCT04775459
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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).

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surfactant administration without using score LUS	Surfactant administration until 2020	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 using score LUS	Surfactant administration since 2021	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

Primary Outcome Measures

Name	Time	Method
administration time frame (min of life)	day 1	Time from birth to surfactant administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu de Saint-Etienne; 🇫🇷 Saint-Étienne, France