NCT01553292

Brief Summary

Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg. The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 24, 2013

Completed
Last Updated

July 24, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

March 6, 2012

Results QC Date

October 5, 2012

Last Update Submit

June 18, 2013

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory distress syndromePreterm infantsVascular catheterSurfactantCPAPECALMIST

Outcome Measures

Primary Outcomes (1)

  • Incidence of Early Ventilation Hours

    The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing

    72 hours

Secondary Outcomes (12)

  • Incidence of Bradycardia During Procedure

    Range of 10 minutes

  • Saturation During the Procedure

    10 minutes

  • Failure to Catheterized the Trachea by the Vascular Catheter

    20 seconds

  • Index Before the Procedure

    1 hour

  • CPAP Pressure After the Procedure

    4 hours

  • +7 more secondary outcomes

Study Arms (1)

ECALMIST

EXPERIMENTAL

Large volume 5ml/kg surfactant administered by vascular catheter while maintaining CPAP or ECALMIST; Early CPAP (continuous positive airway pressure) And Large volume Minimal Invasive Surfactant Therapy

Device: ECALMIST

Interventions

ECALMISTDEVICE

Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP

Also known as: Surfactant administration by catheter
ECALMIST

Eligibility Criteria

Age10 Minutes - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.

You may not qualify if:

  • Infants needs of mechanical ventilation
  • Congenital anomaly
  • Respiratory distress due to non RDS related causes.
  • no parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children hospital of health Sciences Center

Winnipeg, Manitoba, R3C0L8, Canada

Location

Women's Hospital Health Science Center

Winnipeg, Manitoba, R3C0L8, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Limitations and Caveats

This is non randomized interventional feasibility trial, small sample size and in one center

Results Point of Contact

Title
Dr Yahya Al Ethawi
Organization
University of Manitoba
yalethawi@hsc.mb.ca
0012049634721

Study Officials

  • Yahya Al Ethawi, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator MD

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 14, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 24, 2013

Results First Posted

July 24, 2013

Record last verified: 2013-06

Locations

CA(3)