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Lung Ultrasound to Guide Surfactant Therapy

Lung Ultrasound to Guide Surfactant Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04330443
Acronym
ECOSURF
Enrollment
40
Registered
2020-04-01
Start date
2019-03-01
Completion date
2020-05-10
Last updated
2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

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

Interventions

PROCEDURESurfactant therapy

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

Sponsors

Institut Investigacio Sanitaria Pere Virgili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Precocious surfactant administration2 monthtsNumber of patients which receive surfactant therapy during the first 2 hours of life

Secondary

MeasureTime frameDescription
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score2 monthsassess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026