NCT04775459

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
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

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).

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	Surfactant administration until 2020	Surfactant is administrated if Fi02 \>30% among the Guidelines of 2019
DRUG	Surfactant administration since 2021	Surfactant is administrated if Fi02 \>30% OR if score LUS \>8/18 among the literature

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2021-03-01
• Last updated: 2024-06-21

Locations

1 site across 1 country: France