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Lung Ultrasound to Guide Surfactant Therapy (ECOSURF)

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Surfactant therapy
Sponsored by
Institut Investigacio Sanitaria Pere Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital Joan XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultrasound group

Chest X Ray

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2020
Last Updated
May 14, 2020
Sponsor
Institut Investigacio Sanitaria Pere Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT04330443
Brief Title
Lung Ultrasound to Guide Surfactant Therapy
Acronym
ECOSURF
Official Title
Lung Ultrasound to Guide Surfactant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Investigacio Sanitaria Pere Virgili

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound group
Arm Type
Experimental
Arm Description
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
Arm Title
Chest X Ray
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Surfactant therapy
Intervention Description
To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray
Primary Outcome Measure Information:
Title
Precocious surfactant administration
Description
Number of patients which receive surfactant therapy during the first 2 hours of life
Time Frame
2 monthts
Secondary Outcome Measure Information:
Title
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score
Description
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: premature newborns under the gestational age (GA) of 32 weeks old with respiratory distress syndrome Exclusion Criteria: 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
Facility Information:
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Lung Ultrasound to Guide Surfactant Therapy

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