Respiratory Distress SyndromeECALMISTNCT01848262
ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT
A study testing ECALMIST and InSure in people with Respiratory Distress Syndrome, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- ECALMIST and InSure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Lack of parental consent.
- Need for mechanical ventilation
- Major congenital malformation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Health sciences Center
Winnipeg, Manitoba
Yahya Ethawi, MD, 12049634721, yalethawi@hsc.mb.ca
Mohamed Tagin, MD, 12044304250, mtagin@hsc.mb.ca
- Not yet recruiting
St Boniface Hospital
Winnipeg, Manitoba
Yahya Ethawi, MD, 10249634721, yalethawi@hsc.mb.ca
Mohamed Tagin, MD, 12044304250, mtagin@hsc.m.ca
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- ECALMIST, InSure
- Keywords
- ECALMIST, InSurE, CPAP, Ventilation, Vascular Catheter
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECALMISTProcedure or surgery
Also called CPAP and Minimal Invasive Surfactant Therapy
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.
InSureProcedure or surgery
Also called Intubate surfcatant extubate
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.
| Study group | Role | What they receive |
|---|---|---|
| ECALMIST | Active comparator | 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 Receives: Procedure: ECALMIST |
| InSurE | Experimental | 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 Receives: Procedure: InSure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early ventilation hours
The number of the newborn infants needed ventilation in the 1st 3 days of life
Measured: 3 days
Secondary outcomes (6)
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
Measured: 15 minutes
Bradycardia
Decreased heart rate below 100 beat per minutes during ECALMIST or InSurE procedure
Measured: 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
Measured: 15 minutes
Total ventilation hours
Number of total hours during which the newborn are ventilated during hospital admission (form delivery till discharge home)
Measured: 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
Measured: 1st 2 months of life
Early ventilation hours
The mean of ventilation hours
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahya Al Ethawi, University of Manitoba
- Investigators
- Yahya Ethawi, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848262
- Sponsor's protocol ID
- B2013:054
- Acronym
- ECALMIST
- Status last verified
- Feb 2014
- First submitted
- 2 May 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01848262
- Acronym / sponsor ID
- ECALMIST / B2013:054
- Conditions
- Respiratory Distress Syndrome
- Keywords
- ECALMIST, InSurE, CPAP, Ventilation, Vascular Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECALMIST | Active comparator | Procedure: ECALMISTECALMIST 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 |
| InSurE | Experimental | Procedure: InSureInSurE 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 |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Lack of parental consent.
- Need for mechanical ventilation
- Major congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECALMISTAlso: CPAP and Minimal Invasive Surfactant TherapySurfactant 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. | Procedure or surgery | ECALMIST |
| InSureAlso: Intubate surfcatant extubatePatients 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. | Procedure or surgery | InSurE |
Primary outcome
Incidence of early ventilation hours
Time frame: 3 days
The number of the newborn infants needed ventilation in the 1st 3 days of life
6 secondary outcomes
Apnea
Time frame: 15 minutes
Bradycardia
Time frame: 15 minutes
Desaturation
Time frame: 15 minutes
Total ventilation hours
Time frame: hospital admition days
Incidence of Chronic lung disease
Time frame: 1st 2 months of life
Early ventilation hours
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yahya Ethawi, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECALMIST and InSure in people with Respiratory Distress Syndrome, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahya Ethawi, MD (2049634721, yalethawi@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early ventilation hours (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.