NCT01553292

Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 10 Minutes – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	ECALMIST	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
DEVICE	ECALMIST	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

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-03-14
• Last updated: 2013-07-24
• Results posted: 2013-07-24

Locations

3 sites across 1 country: Canada