MISurf Versus InSurE. A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants (MIsurf)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hamilton Health Sciences Corporation.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
elhelous, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01615016
First received: May 30, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

The lungs of infants born too early are extremely underdeveloped. Respiratory Distress Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks early and leads to the collapse of their lungs. Because the lungs had not had enough time to mature, they lack a substance, called surfactant that prevents their collapse. To treat this problem, physicians apply surfactant to the lungs within the first few hours of life by way of the infant's airway using mechanical stimulation (ventilation). Although this treatment has significantly decreased the number of infants who die from RDS, the mechanical ventilation can cause damage to the tiny lungs that may lead to long term lung disease and breathing problems.

The need for more gentle and less invasive methods of deliver the surfactant to the infant has led to the development of two new methods that require little or no mechanical ventilation. While both methods are known to work there is no study that has assessed whether one method is better than the other or causes fewer complications for the infant. The proposed study will determine if it is practical to conduct a clinical trial to compare both methods of surfactant administration and to gather preliminary data on which method gives better results. Should this study look promising, the resulting data will be used to design a larger clinical trial to compare the methods of mechanical ventilation. Results of such a trial would help us to understand the best way to administer surfactant to preterm infants and thus help doctors to better care for tiny infants at risk of lung disease.


Condition Intervention Phase
Hyaline Membrane Disease
Other: Minimally invasive endotracheal surfactant application
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Feasibility Study of A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Proportion of included infants who were treated according to protocol [ Time Frame: Feasibility criteria endpoint after 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recruitment rate [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
    • Recruitment rate
    • Consent rate
    • Proportion of intervention procedures in which masking has not been successful
    • Proportion of interventions, when intervention team has not arrived in time leading to emergency intervention
    • Success rate in antenatal approach for consent


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MISurf
Minimally Surfactant application via small tube inserted into the trachea under CPAP therapy without formal intubation and without mechanical ventilation
Other: Minimally invasive endotracheal surfactant application

What are the planned trial interventions?

  1. MISurf: Minimally invasive intratracheal surfactant application without mechanical ventilation by feeding tube device
  2. InSurE: Surfactant application by InSurE strategy (Intubation - surfactant - extubation sequence).

Both interventions will be performed by intervention teams. For the MISurf intervention, it was decided to use the minimally invasive method via feeding tube exclusively due to concerns about possibility of airway injury with the iv cannula device.

Surfactant Two porcine derived surfactant products have been used in the published trials for minimal invasive surfactant application, Curosurf© and Survanta©. Due to safety reasons we will use these products also in our pilot study however, only the latter is currently available in Canada. Hence we will use Survanta© 100 mg/kgBW, equivalent to 4 ml/kgBW per dose.19,20,26

Other Names:
  • Surfactant Application via feeding tube.
  • Non invasive surfactant application.
Active Comparator: InSurE
Surfactant application via Intubation - Surfactant Application - Extubation sequence
Other: Minimally invasive endotracheal surfactant application

What are the planned trial interventions?

  1. MISurf: Minimally invasive intratracheal surfactant application without mechanical ventilation by feeding tube device
  2. InSurE: Surfactant application by InSurE strategy (Intubation - surfactant - extubation sequence).

Both interventions will be performed by intervention teams. For the MISurf intervention, it was decided to use the minimally invasive method via feeding tube exclusively due to concerns about possibility of airway injury with the iv cannula device.

Surfactant Two porcine derived surfactant products have been used in the published trials for minimal invasive surfactant application, Curosurf© and Survanta©. Due to safety reasons we will use these products also in our pilot study however, only the latter is currently available in Canada. Hence we will use Survanta© 100 mg/kgBW, equivalent to 4 ml/kgBW per dose.19,20,26

Other Names:
  • Surfactant Application via feeding tube.
  • Non invasive surfactant application.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 36 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible are all preterm infants born ≤ 30 weeks gestation at McMaster Inclusion criteria

  • CPAP of 5-6 cm H2O and FiO2≥ 0.35 or CPAP of 7-8 cm of H2O and FiO2≥ 0.30.21,22,26
  • Less than 36 hours of age
  • Worsening clinical signs of RDS such as retractions (clinical judgment of the responsible physician)

Exclusion Criteria:

  • Previous Intubation or in imminent need of invasive mechanical ventilation because of e.g. apnea, severe bradycardia or other deterioration not attributed to RDS, e.g. shock
  • Congenital anomaly or conditions that might adversely affect breathing
  • Pneumothorax before intervention
  • No parental consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615016

Contacts
Contact: Salhab el Helou, MD/AssocProf 9055212100 ext 73490 elhelos@mcmaster.ca
Contact: Christoph Fusch, MD/Professor 9055212100 ext 75721 fusch@mcmaster.ca

Locations
Canada, Ontario
McMaster University Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Principal Investigator: Salhab el Helou, MD/AssocProf         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Salhab el Helou, MD/AssocProf McMaster University Children's Hospital/Hamilton Health Sciences
  More Information

No publications provided

Responsible Party: elhelous, Dr. med. / Associate Professor, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01615016     History of Changes
Other Study ID Numbers: NIF-12295
Study First Received: May 30, 2012
Last Updated: June 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences Corporation:
Preterm infant
Surfactant application
Respiratory Distress Syndrome
Minimally invasive Surfactant Application
INSURE (Intubate-Surfactant-Extubate)

Additional relevant MeSH terms:
Hyaline Membrane Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014