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

Respiratory Distress Syndrome Clinical Trial

— ECALMIST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553292
• Other study ID #: B2012:016
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: June 18, 2013
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Children hospital of health Sciences Center	Winnipeg	Manitoba
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Canada	Women's Hospital Health Science Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Early Ventilation Hours	The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing	72 hours	No
Secondary	Incidence of Bradycardia During Procedure	Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.	Range of 10 minutes	Yes
Secondary	Saturation During the Procedure	Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.	10 minutes	Yes
Secondary	Failure to Catheterized the Trachea by the Vascular Catheter	Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.	20 seconds	Yes
Secondary	Index Before the Procedure	The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.; FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.	1 hour	Yes
Secondary	CPAP Pressure After the Procedure	Continuous positive airway pressure (CPAP) is measured in centimeter of water	4 hours	Yes
Secondary	Oxygen Requirement Before the Procedure	Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.	1 hour	Yes
Secondary	Oxygen Saturation After the Procedure	Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.	4 hours	Yes
Secondary	Index After the Procedure	The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.; FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.	4 hours	Yes
Secondary	CPAP Pressure Before the Proceudre	Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)	1 hour	Yes
Secondary	Oxygen Saturation Before the Procedure	Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.	1 hour	Yes
Secondary	Oxygen Requirements After the Procedure	Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.	4 hours	Yes
Secondary	Needs for Intubation During the Procedure	The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)	10 minutes	Yes