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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yahya Al Ethawi, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01553292
First received: March 6, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Respiratory Distress Syndrome
Device: ECALMIST

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Incidence of Early Ventilation Hours [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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:
  • Incidence of Bradycardia During Procedure [ Time Frame: Range of 10 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Saturation During the Procedure [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 20 seconds ] [ Designated as safety issue: Yes ]
    Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.

  • Index Before the Procedure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    Continuous positive airway pressure (CPAP) is measured in centimeter of water

  • Oxygen Requirement Before the Procedure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)

  • Oxygen Saturation Before the Procedure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)


Enrollment: 21
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Surfactant administration by catheter

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553292

Locations
Canada, Manitoba
Children hospital of health Sciences Center
Winnipeg, Manitoba, Canada, R3C0L8
Women's Hospital Health Science Center
Winnipeg, Manitoba, Canada, R3C0L8
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Yahya Al Ethawi, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Yahya Al Ethawi, Principal Investigator MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01553292     History of Changes
Other Study ID Numbers: B2012:016
Study First Received: March 6, 2012
Results First Received: October 5, 2012
Last Updated: June 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Respiratory distress syndrome
Preterm infants
Vascular catheter
Surfactant
CPAP
ECALMIST

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014