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)

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

Sponsors

Lead sponsor: University of Manitoba

Source University of Manitoba
Brief 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.

Overall Status Completed
Start Date April 2012
Completion Date September 2012
Primary Completion Date September 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Early Ventilation Hours 72 hours
Secondary Outcome
Measure Time Frame
Incidence of Bradycardia During Procedure Range of 10 minutes
Saturation During the Procedure 10 minutes
Failure to Catheterized the Trachea by the Vascular Catheter 20 seconds
Index Before the Procedure 1 hour
CPAP Pressure After the Procedure 4 hours
Oxygen Requirement Before the Procedure 1 hour
Oxygen Saturation After the Procedure 4 hours
Index After the Procedure 4 hours
CPAP Pressure Before the Proceudre 1 hour
Oxygen Saturation Before the Procedure 1 hour
Oxygen Requirements After the Procedure 4 hours
Needs for Intubation During the Procedure 10 minutes
Enrollment 21
Condition
Intervention

Intervention type: Device

Intervention name: ECALMIST

Description: 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

Arm group label: ECALMIST

Other name: Surfactant administration by catheter

Intervention type: Device

Intervention name: ECALMIST

Description: 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

Arm group label: ECALMIST

Other name: Surfactant administration by catheter

Eligibility

Criteria:

Inclusion Criteria:

-preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.

Exclusion Criteria:

- Infants needs of mechanical ventilation

- Congenital anomaly

- Respiratory distress due to non RDS related causes.

- no parental consent

Gender: All

Minimum age: N/A

Maximum age: 24 Hours

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Yahya Al Ethawi, MD Principal Investigator University of Manitoba
Location
facility
Children hospital of health Sciences Center | Winnipeg, Manitoba, R3C0L8, Canada
Women's Hospital Health Science Center | Winnipeg, Manitoba, R3C0L8, Canada
St. Boniface Hospital | Winnipeg, Manitoba, Canada
Location Countries

Canada

Verification Date

June 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Manitoba

Investigator full name: Yahya Al Ethawi

Investigator title: Principal Investigator MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ECALMIST

Arm group type: Experimental

Description: Large volume 5ml/kg surfactant administered by vascular catheter while maintaining CPAP or ECALMIST; Early CPAP (continuous positive airway pressure) And Large volume Minimal Invasive Surfactant Therapy

Acronym ECALMIST
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov