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

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ClinicalTrials.gov Identifier: NCT01848262
Recruitment Status : Unknown
Verified February 2014 by Yahya Al Ethawi, University of Manitoba.
Recruitment status was:  Recruiting
First Posted : May 7, 2013
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Yahya Al Ethawi, University of Manitoba

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Incidence of early ventilation hours [ Time Frame: 3 days ]
The number of the newborn infants needed ventilation in the 1st 3 days of life
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
Early Ventilation hours [ Time Frame: 3 days ]
The number of hours during which the newborn infants on ventilator in the 1st 3 days of life
Change History Complete list of historical versions of study NCT01848262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
  • 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)
  • Chronic lung disease [ Time Frame: 1st 2 months of life ]
    The need for oxygen support at 28 days or postnatal life and at the 36 weeks of corrected postnatal age
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2013)
Hospital stay [ Time Frame: 1st three months of life ]
The number of days that newborn spent in the hospital after delivery
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: ECALMIST
  • 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
    Intervention: Procedure: InSure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 31 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848262
Other Study ID Numbers  ICMJE B2013:054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yahya Al Ethawi, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yahya Ethawi, MD University of Manitoba
PRS Account University of Manitoba
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP