Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called
      ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is
      needed to adapt the use of large volume surfactant of 4-5 ml/kg.

      The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada
      called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation
      suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on
      CPAP.
    

Detailed description: 
      The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without
      premedication while the infant is maintained on continuous positive airway pressure (CPAP.
      The the laryngoscope should be removed after stabilizing the vascular catheter between 2
      fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of
      0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital
      signs.

      The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen
      requirement might need to adjusted to restore baseline vital signs. If the vital signs
      remained unstable the catheter should be removed and the infant managed according by positive
      pressure ventilation (PPV) or intubation by endotracheal tube (ETT).

      At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter
      should be removed.

      FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded
      before during and after the procedure.

      Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of
      respiration for more than 20 second or less than 20 seconds but associated with bradycardia)
      All other neonatal outcome will be recorded (IVH [Intra-ventricular Hemorrhage], ROP
      [Retinopathy of prematurity], duration of ventilation, duration of hospital stay, infection,
      duration of oxygen requirement and others.
    

Intervention name(s): ECALMIST; ECALMIST
Intervention type(s): Device; Device
Intervention description(s): Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP; Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP
Other intervention name(s): Surfactant administration by catheter; Surfactant administration by catheter
Intervention MeSH terms: Pulmonary Surfactants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory distress syndrome; Preterm infants; Vascular catheter; Surfactant; CPAP; ECALMIST