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ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT (ECALMIST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yahya Al Ethawi, University of Manitoba.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01848262
First Posted: May 7, 2013
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yahya Al Ethawi, University of Manitoba
  Purpose
Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective randomized clinical trial.

Condition Intervention
Respiratory Distress Syndrome Procedure: ECALMIST Procedure: InSure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) Versus InSurE (Intubate, Surfactant, Extubate) in Preterm Infants With Respiratory Distress Syndrome (RDS): Prospective Randomised Control Clinical Trial

Resource links provided by NLM:


Further study details as provided by Yahya Al Ethawi, University of Manitoba:

Primary Outcome Measures:
  • Incidence of early ventilation hours [ Time Frame: 3 days ]
    The number of the newborn infants needed ventilation in the 1st 3 days of life


Secondary Outcome Measures:
  • Apnea [ Time Frame: 15 minutes ]
    Pause or stop of breathing for more than 20 seconds or stop of breathing that associated with decrease oxygen saturation below 75% or decrease heart rate below 100 during ECALMIST or InSurE method of surfactant therapy

  • Bradycardia [ Time Frame: 15 minutes ]
    Decreased heart rate below 100 beat per minutes during ECALMIST or InSurE procedure

  • Desaturation [ Time Frame: 15 minutes ]
    Decreased level of oxygen saturation measured by pulse oximeter to below 75% for more than 20 seconds during either ECALMIST or InSurE

  • Total ventilation hours [ Time Frame: hospital admition days ]
    Number of total hours during which the newborn are ventilated during hospital admission (form delivery till discharge home)

  • Incidence of Chronic lung disease [ Time Frame: 1st 2 months of life ]
    The incidence of Chronic lung disease (CLD) both definitions; the need for oxygen support at 28 days of postnatal life and at the 36 weeks of corrected postnatal age

  • Early ventilation hours [ Time Frame: 3 days ]
    The mean of ventilation hours


Other Outcome Measures:
  • Hospital stay [ Time Frame: 1st three months of life ]
    The number of days that newborn spent in the hospital after delivery


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ECALMIST
ECALMIST will be used in preterm infants between 24 weeks to 31 weeks in the 1st day of life with RDS and spontaneously breathing with decision to give surfactant
Procedure: ECALMIST
Surfactant administration via 17 (5 French) gauge, 133 mm length vascular catheter. 5 ml/kg will be drawn up in a 5 or 10 ml syringe. The vascular catheter will be inserted through the vocal cords under direct vision using a standard laryngoscope with the appropriate blade for gestational age. The procedure will be done without removing the NCPAP. A bolus of surfactant of 0.25-0.5 ml will be administered, after observing the surfactant moving up and down as indication of accurate intubation of the trachea. The surfactant will be slowly injected by small pulses of 0.25-0.5 ml over 20-30 seconds, each bolus with 10 seconds apart. At the end of the procedure, the operator will flush the catheter with 0.5 ml of air before removing the catheter.
Other Name: CPAP and Minimal Invasive Surfactant Therapy
Experimental: InSurE
InSurE will be used in preterm infants between 24 weeks to 31 weeks in the 1st day of life with RDS and spontaneously breathing with decision to give surfactant
Procedure: InSure
Patients who will receive surfactant via this technique will have their NCPAP removed and then they will be orally intubated with a standard endotracheal tube (ETT) using standard endotracheal intubation procedures using appropriate size ETT according to the birth weight. Bovine surfactant will be administered through the ETT using the same technique described above for arm 1. Manual lung inflation using a Jackson -Rees anesthesia bag at 20/5-cm H2O pressure will be performed during the surfactant instillation after which the patient will be extubated promptly as per the discretion of the neonatal team. Immediately following extubation, nCPAP support will be recommenced. No premedication, such as sedation or atropine, will be used during either procedure.
Other Name: Intubate surfcatant extubate

Detailed Description:

After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or NCPAP.

General guidelines for reintubation include persistent pH<7.20, PaCO2 > 65 mmHg, very frequent apnea (>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations >3/hour not responding to increase in FiO2 or increase in FiO2 to 100%), or apneas requiring prolonged PPV. For the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All should apply:

  • Newborn less than 32 weeks gestation at birth
  • Postnatal age < 24 hrs of life
  • Clinical diagnosis of RDS
  • Spontaneously breathing on NCPAP
  • Clinical decision to give surfactant.

Exclusion Criteria:

  • Lack of parental consent.
  • Need for mechanical ventilation
  • Major congenital malformation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848262


Contacts
Contact: Yahya Ethawi, MD 2049634721 yalethawi@hsc.mb.ca
Contact: Abrar Hussain, MD 2047719301 ahussain3@hsc.mb.ca

Locations
Canada, Manitoba
Health sciences Center Recruiting
Winnipeg, Manitoba, Canada
Contact: Yahya Ethawi, MD    12049634721    yalethawi@hsc.mb.ca   
Contact: Mohamed Tagin, MD    12044304250    mtagin@hsc.mb.ca   
Principal Investigator: Yahya Ethawi, MD         
Sub-Investigator: Ruben Alvaro, MD         
Sub-Investigator: Mary Seshia, MD         
Sub-Investigator: Abrar Abrar Hussain, MD         
Sub-Investigator: Yasser Ali, MD         
Sub-Investigator: John Minski, RTT         
Sub-Investigator: Mohammad Al Yahmadi, MD         
Sub-Investigator: Iram Musharaf, MD         
Sub-Investigator: Mohamed Tagin, MD         
St Boniface Hospital Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Yahya Ethawi, MD    10249634721    yalethawi@hsc.mb.ca   
Contact: Mohamed Tagin, MD    12044304250    mtagin@hsc.m.ca   
Principal Investigator: Yahya Ethawi, MD         
Sub-Investigator: Ruben Alvaro, MD         
Sub-Investigator: Mary Seshia, MD         
Sub-Investigator: Abrar Hussain, MD         
Sub-Investigator: John Misnki, RTT         
Sub-Investigator: Yasser Ali, MD         
Sub-Investigator: Mohammed Al Yahmadi, MD         
Sub-Investigator: Iram Musharaf, MD         
Sub-Investigator: Joe Millar, RTT         
Sub-Investigator: Mohamed Tagin, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Yahya Ethawi, MD University of Manitoba
  More Information

Responsible Party: Yahya Al Ethawi, Dr, University of Manitoba
ClinicalTrials.gov Identifier: NCT01848262     History of Changes
Other Study ID Numbers: B2013:054
First Submitted: May 2, 2013
First Posted: May 7, 2013
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Yahya Al Ethawi, University of Manitoba:
ECALMIST
InSurE
CPAP
Ventilation
Vascular Catheter

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents