Clinical trial NCT04775459: Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Preterm
Lung Ultrasound Score
Surfactant
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 84
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: administration time frame (min of life)
timeFrame: day 1
Secondary outcomes:
measure: FiO2 maximum
timeFrame: Week 1
measure: delay from FiO2 maximum to FiO2 < 21%
timeFrame: Week 4
measure: Ventilation time (day)
timeFrame: Week 4
measure: Ventilation support
timeFrame: Week 4
measure: Bronchodysplasia rate
timeFrame: Week 4
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Aurelie CANTAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: