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

Not Applicable

Completed

Conditions: Respiratory Distress Syndrome

Interventions: Device: ECALMIST

Registration Number: NCT01553292

Lead Sponsor: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECALMIST	ECALMIST	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

Primary Outcome Measures

Name	Time	Method
Incidence of Early Ventilation Hours	72 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

Secondary Outcome Measures

Name	Time	Method
Incidence of Bradycardia During Procedure	Range of 10 minutes	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.
Index Before the Procedure	1 hour	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.
CPAP Pressure After the Procedure	4 hours	Continuous positive airway pressure (CPAP) is measured in centimeter of water
Oxygen Requirement Before the Procedure	1 hour	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.
Oxygen Saturation After the Procedure	4 hours	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.
Index After the Procedure	4 hours	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.
CPAP Pressure Before the Proceudre	1 hour	Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)
Saturation During the Procedure	10 minutes	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.
Failure to Catheterized the Trachea by the Vascular Catheter	20 seconds	Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.
Oxygen Saturation Before the Procedure	1 hour	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.
Oxygen Requirements After the Procedure	4 hours	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%.
Needs for Intubation During the Procedure	10 minutes	The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)

Trial Locations

Locations (3): St. Boniface Hospital
🇨🇦
Winnipeg, Manitoba, Canada
Women's Hospital Health Science Center
🇨🇦
Winnipeg, Manitoba, Canada
Children hospital of health Sciences Center
🇨🇦
Winnipeg, Manitoba, Canada