Lung Ultrasound to Guide Surfactant Therapy
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

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
    

Intervention name(s): Surfactant therapy
Intervention type(s): Procedure
Intervention description(s): To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment