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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Feasibility Study of A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants

Brief 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.


Detailed Summary:

  1. The Need for a Trial What is the problem to be addressed? Respiratory distress syndrome (RDS) is a major clinical challenge affecting 60% of babies born before 30 weeks gestation and significantly contributes to mortality and morbidity in very preterm infants, including chronic lung disease and bronchopulmonary dysplasia. Given that the immature lungs of these tiny infants are developmentally deficient in surfactant, exogenous surfactant administration might be beneficial to prevent pulmonary atelectasis. The traditional method in preterm infants is via endotracheal tube accompanied by mechanical ventilation using positive pressure. The latter predisposes to permanent lung injury.This study seeks to assess the feasibility of conducting a large-scale clinical trial to compare two minimally invasive methods of surfactant administration to very low birth weight preterm infants. As such a comparative study has not been reported, the proposed study is a pilot trial to test the feasibility of the study design and to gather preliminary data on the comparison of two methods of surfactant administration. Results from this study will inform the design of a larger clinical trial including appropriate power calculation.

    Current management of lung disease in preterm infants RDS significantly contributes to mortality and morbidity in very preterm infants and is, itself, a major determinant of chronic lung disease (CLD) in the premature infant. One of the most common causes of RDS is surfactant deficiency; therefore, exogenous surfactant is frequently used for the treatment of RDS of the preterm infant. Endogenous surfactant is typically produced by alveolar cells type II and this substance, among other functions, decreases and modulates the surface tension in the small gas exchanging units of the lung, the a
    Sponsor: Hamilton Health Sciences Corporation

    Current Primary Outcome: Proportion of included infants who were treated according to protocol [ Time Frame: Feasibility criteria endpoint after 12 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Recruitment rate [ Time Frame: 1 year. ]

    • 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


    Original Secondary Outcome: Same as current

    Information By: Hamilton Health Sciences Corporation

    Dates:
    Date Received: May 30, 2012
    Date Started: July 2012
    Date Completion: December 2015
    Last Updated: March 19, 2015
    Last Verified: March 2015