Lung Ultrasound to Guide Surfactant Therapy

NCT04330443 | Completed DMC

• 1 other identifier: 136/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) \>90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter). Exclusion criteria are non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the lung ultrasound. The main objective of the study is to determine if a diagnostic of respiratory distress syndrome guided by a lung ultrasound algorithm allow an earlier surfactant therapy (within the first 2 hours of life) comparing to chest X ray Secondary objectives were to assess FiO2 reached before surfactant therapy in patients surfacted according to the lung ultrasound score, the influence of the lung ultrasound algorithm regarding the respiratory evolution, and its differences comparing to the FiO2group. Respiratory evolution was defined as the need of mechanical ventilation, second dose of surfactant, duration of non invasive ventilation, number of days with oxygen requirements, length of stay in the neonatal intensive care unit, evolution to bronchopulmonary dysplasia and their progression to discharge from hospital. Patients who met the inclusion criteria were randomly assigned to two groups. using the "random" function in MS-Excel XP® program. A total of 6 physicians enrolled participants, all them fully trained for the use of lung ultrasound. The principal investigator assigned participants to interventions, depending on the randomized list.

• Experimental Group 1: The neonatologist-researcher (NR) performed the lung ultrasond at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than \>8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life . This lung ultrasound threshold is the one with best diagnostic accuracy.
• Control Group 2: The NR performed the at admission/suspicion during the first hour of life. The NA was not blinded to the result of the ultrasound. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Precocious surfactant administration

  Number of patients which receive surfactant therapy during the first 2 hours of life

  2 monthts

Secondary Outcomes (1)

• assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score

  2 months

Study Arms (2)

Ultrasound group

EXPERIMENTAL

The neonatologist-researcher (NR) performed the lung ultrasound at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than \>8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life

Procedure: Surfactant therapy

Chest X Ray

NO INTERVENTION

The NR performed the LUS at admission/suspicion during the first hour of life. The NA was not blinded to the result of the LUS. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life

Interventions

Surfactant therapy PROCEDURE

To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray

Ultrasound group

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• premature newborns under the gestational age (GA) of 32 weeks old with respiratory distress syndrome

You may not qualify if:

• non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the ultrasoundLUS

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Hospital Joan XXIII

Tarragona, Spain

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 1, 2020
• Study Start: March 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 10, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)