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

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT01553292
• Collaborator: (none)
• Enrollment: 21
• Locations: 3
• Arm: 1
• Duration (Months): 5
• Patients Per Site: 7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Device: ECALMIST; Device: ECALMIST	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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

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; Other Names: Surfactant administration by catheter ; 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; Other Names: Surfactant administration by catheter

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. CPAP Pressure After the Procedure [4 hours]

   Continuous positive airway pressure (CPAP) is measured in centimeter of water

6. 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.

7. 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.

8. 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.

9. 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)

10. 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.

11. 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%.

12. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Minutes to 24 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children hospital of health Sciences Center	Winnipeg	Manitoba	Canada	R3C0L8
2	Women's Hospital Health Science Center	Winnipeg	Manitoba	Canada	R3C0L8
3	St. Boniface Hospital	Winnipeg	Manitoba	Canada

Sponsors and Collaborators

• University of Manitoba

Investigators

• Principal Investigator: Yahya Al Ethawi, MD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yahya Al Ethawi, Principal Investigator MD, University of Manitoba
• ClinicalTrials.gov Identifier: NCT01553292
• Other Study ID Numbers: B2012:016
• First Posted: Mar 14, 2012
• Last Update Posted: Jul 24, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Yahya Al Ethawi, Principal Investigator MD, University of Manitoba: Respiratory distress syndrome; Preterm infants; Vascular catheter; Surfactant; CPAP; ECALMIST
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome; Pulmonary Surfactants

Study Results

Participant Flow

Recruitment Details	The recruitment period was of 2 months duration form July 5th, 2012 to September 5th, 2012 in 3 hospitals (St Boniface NICU, Children hospital's NICU and Women's hospital delivery room at HSC).

Arm/Group Title	Surfactant Through Vascular Catheter
Arm/Group Description	Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
Period Title: Overall Study
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Angiocath Surfactant
Arm/Group Description	Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Overall Participants	21
Age (Count of Participants)
<=18 years	21 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	29 (3)
Sex: Female, Male (Count of Participants)
Female	12 57.1%
Male	9 42.9%
Region of Enrollment (participants) [Number]
Canada	21 100%

Outcome Measures

1. Secondary Outcome

Title	Incidence of Bradycardia During Procedure
Description	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.
Time Frame	Range of 10 minutes

Outcome Measure Data

Analysis Population Description

The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Number [Number of participants]	3 14.3%

2. Secondary Outcome

Title	Saturation During the Procedure
Description	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.
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Proportion of oxygen saturation]	0.87 (0.08)

3. Secondary Outcome

Title	Failure to Catheterized the Trachea by the Vascular Catheter
Description	Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.
Time Frame	20 seconds

Outcome Measure Data

Analysis Population Description

Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Number [Number of participants]	1 4.8%

4. Primary Outcome

Title	Incidence of Early Ventilation Hours
Description	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
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery)

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Number [Number of participants]	4 19%

5. Secondary Outcome

Title	Index Before the Procedure
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

The mean of index of all participants before ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Score]	2.61 (0.81)

6. Secondary Outcome

Title	CPAP Pressure After the Procedure
Description	Continuous positive airway pressure (CPAP) is measured in centimeter of water
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Centimeter of water]	5.8 (0.471)

7. Secondary Outcome

Title	Oxygen Requirement Before the Procedure
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

The mean of oxygen requirement of all the participants before ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Proportion of oxygen requirement]	0.308 (0.068)

8. Secondary Outcome

Title	Oxygen Saturation After the Procedure
Description	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.
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

The mean of oxygen saturation after ECALMIST for all the participants

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Proportion of oxygen saturation]	0.94 (0.04)

9. Secondary Outcome

Title	Index After the Procedure
Description	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.
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

The mean of ECALMIST index of all the participants after ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Score]	1.27 (1.8)

10. Secondary Outcome

Title	CPAP Pressure Before the Proceudre
Description	Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Centimeter of water]	7.1 (0.447)

11. Secondary Outcome

Title	Oxygen Saturation Before the Procedure
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

The mean of saturation of all participants before ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Proportion of oxygen saturation]	0.87 (0.08)

12. Secondary Outcome

Title	Oxygen Requirements After the Procedure
Description	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%.
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

The mean of oxygen level (proportion) of all participant after ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Mean (Standard Deviation) [Proportion of oxygen saturation]	0.257 (0.084)

13. Secondary Outcome

Title	Needs for Intubation During the Procedure
Description	The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST

Arm/Group Title	Surfactant Administration Through Vascular Catheter
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Measure Participants	21
Number [Number of participants]	3 14.3%

Adverse Events

Arm/Group Title	Angiocath Surfactant
Arm/Group Description	Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
All Cause Mortality
	Angiocath Surfactant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Angiocath Surfactant
	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)
Cardiac disorders
Brady cardia	1/21 (4.8%)	21
Respiratory, thoracic and mediastinal disorders
de-saturation	3/21 (14.3%)	21
Other (Not Including Serious) Adverse Events
	Angiocath Surfactant
	Affected / at Risk (%)	# Events
Total	0/21 (0%)

Limitations/Caveats

This is non randomized interventional feasibility trial, small sample size and in one center

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.