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

NCT01615016 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Hyaline Membrane Disease

Interventions

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

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Salhab el Helou, MD/AssocProf · McMaster University Children's Hospital/Hamilton Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
36 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-08-19
Completion
2017-08-19

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615016 on ClinicalTrials.gov