Respiratory Distress Syndrome Clinical Trial
Official title:
Lung Ultrasound to Guide Surfactant Therapy
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
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
;
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