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

NCT04775459 | Completed

• 1 other identifier: IRBN232021/CHUSTE
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Birth

Keywords

Preterm; Lung Ultrasound Score; Surfactant

Outcome Measures

Primary Outcomes (1)

• administration time frame (min of life)

  Time from birth to surfactant administration

  day 1

Secondary Outcomes (5)

• FiO2 maximum

  Week 1

• delay from FiO2 maximum to FiO2 < 21%

  Week 4

• Ventilation time (day)

  Week 4

• Ventilation support

  Week 4

• Bronchodysplasia rate

  Week 4

Study Arms (2)

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 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

Interventions

Surfactant administration until 2020 DRUG

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

Also known as: No LUS

Surfactant administration without using score LUS

Surfactant administration since 2021 DRUG

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

Also known as: With LUS

Surfactant administration using score LUS

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• newborns \<33 weeks old
• born at the Saint Etienne University Hospital
• respiratory distress syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aurelie CANTAIS, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: January 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)