An interventional study of Surfactant therapy in Respiratory Distress Syndrome, sponsored by Institut Investigacio Sanitaria Pere Virgili. Completed at 1 site in Spain. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Not applicable, Interventional, and Treatment
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 35 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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
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
To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray
Precocious surfactant administration
Number of patients which receive surfactant therapy during the first 2 hours of life
Time frame: 2 monthts
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
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Institut Investigacio Sanitaria Pere Virgili