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

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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: ECALMIST; Procedure: InSure

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yahya Ethawi, MD; Phone Number: 2049634721; Email: yalethawi@hsc.mb.ca
• Study Contact Backup: Name: Abrar Hussain, MD; Phone Number: 2047719301; Email: ahussain3@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • Health Sciences Center
      • Contact: Yahya Ethawi, MD; Phone Number: 12049634721; Email: yalethawi@hsc.mb.ca
      • Contact: Mohamed Tagin, MD; Phone Number: 12044304250; Email: 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
    • Winnipeg, Manitoba, Canada
      • Not yet recruiting
      • St Boniface Hospital
      • Principal Investigator: Yahya Ethawi, MD
      • Sub-Investigator: Ruben Alvaro, MD
      • Sub-Investigator: Mary Seshia, MD
      • Sub-Investigator: Yasser Ali, MD
      • Sub-Investigator: Iram Musharaf, MD
      • Sub-Investigator: Mohamed Tagin, MD
      • Contact: Yahya Ethawi, MD; Phone Number: 10249634721; Email: yalethawi@hsc.mb.ca
      • Contact: Mohamed Tagin, MD; Phone Number: 12044304250; Email: mtagin@hsc.m.ca
      • Sub-Investigator: Abrar Hussain, MD
      • Sub-Investigator: John Misnki, RTT
      • Sub-Investigator: Mohammed Al Yahmadi, MD
      • Sub-Investigator: Joe Millar, RTT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Intubate surfcatant extubate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of early ventilation hours	The number of the newborn infants needed ventilation in the 1st 3 days of life	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea	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	15 minutes
Bradycardia	Decreased heart rate below 100 beat per minutes during ECALMIST or InSurE procedure	15 minutes
Desaturation	Decreased level of oxygen saturation measured by pulse oximeter to below 75% for more than 20 seconds during either ECALMIST or InSurE	15 minutes
Total ventilation hours	Number of total hours during which the newborn are ventilated during hospital admission (form delivery till discharge home)	hospital admition days
Incidence of Chronic lung disease	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	1st 2 months of life
Early ventilation hours	The mean of ventilation hours	3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	The number of days that newborn spent in the hospital after delivery	1st three months of life

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Yahya Ethawi, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 9, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: CPAP; Ventilation; InSurE; ECALMIST; Vascular Catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: B2013:054