Respiratory Distress Syndrome Clinical Trial
Official title:
Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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