Trial Outcomes & Findings for Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS (NCT NCT01553292)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

72 hours

Results posted on

2013-07-24

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Surfactant Through Vascular Catheter 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
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Angiocath Surfactant n=21 Participants 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)
Age, Categorical <=18 years	21 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	29 Weeks STANDARD_DEVIATION 3 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment Canada	21 participants n=99 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: 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)

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

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Incidence of Early Ventilation Hours	4 Number of participants

SECONDARY outcome

Timeframe: Range of 10 minutes

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Incidence of Bradycardia During Procedure	3 Number of participants

SECONDARY outcome

Timeframe: 10 minutes

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

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Saturation During the Procedure	0.87 Proportion of oxygen saturation Standard Deviation 0.08

SECONDARY outcome

Timeframe: 20 seconds

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

Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Failure to Catheterized the Trachea by the Vascular Catheter	1 Number of participants

SECONDARY outcome

Timeframe: 1 hour

Population: The mean of index of all participants before ECALMIST

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Index Before the Procedure	2.61 Score Standard Deviation 0.81

SECONDARY outcome

Timeframe: 4 hours

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

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

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
CPAP Pressure After the Procedure	5.8 Centimeter of water Standard Deviation 0.471

SECONDARY outcome

Timeframe: 1 hour

Population: The mean of oxygen requirement of all the participants before ECALMIST

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Oxygen Requirement Before the Procedure	0.308 Proportion of oxygen requirement Standard Deviation 0.068

SECONDARY outcome

Timeframe: 4 hours

Population: The mean of oxygen saturation after ECALMIST for all the participants

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Oxygen Saturation After the Procedure	0.94 Proportion of oxygen saturation Standard Deviation 0.04

SECONDARY outcome

Timeframe: 4 hours

Population: The mean of ECALMIST index of all the participants after ECALMIST

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Index After the Procedure	1.27 Score Standard Deviation 1.8

SECONDARY outcome

Timeframe: 1 hour

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

Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
CPAP Pressure Before the Proceudre	7.1 Centimeter of water Standard Deviation 0.447

SECONDARY outcome

Timeframe: 1 hour

Population: The mean of saturation of all participants before ECALMIST

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.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Oxygen Saturation Before the Procedure	0.87 Proportion of oxygen saturation Standard Deviation 0.08

SECONDARY outcome

Timeframe: 4 hours

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

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%.

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Oxygen Requirements After the Procedure	0.257 Proportion of oxygen saturation Standard Deviation 0.084

SECONDARY outcome

Timeframe: 10 minutes

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

The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)

Outcome measures

Outcome measures
Measure	Surfactant Administration Through Vascular Catheter n=21 Participants Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Needs for Intubation During the Procedure	3 Number of participants

Adverse Events

Angiocath Surfactant

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Angiocath Surfactant n=21 participants at risk Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
Cardiac disorders Brady cardia	4.8% 1/21 • Number of events 21
Respiratory, thoracic and mediastinal disorders de-saturation	14.3% 3/21 • Number of events 21

Other adverse events

Adverse event data not reported

Additional Information

Dr Yahya Al Ethawi

University of Manitoba

Phone: 0012049634721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place