NCT01848262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

May 2, 2013

Last Update Submit

February 9, 2014

Conditions

Respiratory Distress Syndrome

Keywords

ECALMISTInSurECPAPVentilationVascular Catheter

Outcome Measures

Primary Outcomes (1)

  • Incidence of early ventilation hours

    The number of the newborn infants needed ventilation in the 1st 3 days of life

    3 days

Secondary Outcomes (6)

  • Apnea

    15 minutes

  • Bradycardia

    15 minutes

  • Desaturation

    15 minutes

  • Total ventilation hours

    hospital admition days

  • Incidence of Chronic lung disease

    1st 2 months of life

  • +1 more secondary outcomes

Other Outcomes (1)

  • Hospital stay

    1st three months of life

Study Arms (2)

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

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

Procedure: InSure

Interventions

ECALMISTPROCEDURE

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.

Also known as: CPAP and Minimal Invasive Surfactant Therapy
ECALMIST
InSurePROCEDURE

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.

Also known as: Intubate surfcatant extubate
InSurE

Eligibility Criteria

Age24 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of parental consent.
  • Need for mechanical ventilation
  • Major congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health sciences Center

Winnipeg, Manitoba, Canada

RECRUITING

St Boniface Hospital

Winnipeg, Manitoba, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Aspiration

Interventions

Insure Cement

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yahya Ethawi, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahya Ethawi, MD

CONTACT

2049634721yalethawi@hsc.mb.ca

Abrar Hussain, MD

CONTACT

2047719301ahussain3@hsc.mb.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 7, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

CA(2)