MISurf Versus InSurE. A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants (MIsurf)
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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 |
- Proportion of included infants who were treated according to protocol [ Time Frame: Feasibility criteria endpoint after 12 months ] [ Designated as safety issue: Yes ]
- 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?
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:
|
|
Active Comparator: InSurE
Surfactant application via Intubation - Surfactant Application - Extubation sequence
|
Other: Minimally invasive endotracheal surfactant application
What are the planned trial interventions?
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 36 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Salhab el Helou, MD/AssocProf | 9055212100 ext 73490 | elhelos@mcmaster.ca |
| Contact: Christoph Fusch, MD/Professor | 9055212100 ext 75721 | fusch@mcmaster.ca |
| Canada, Ontario | |
| McMaster University Children's Hospital | Not yet recruiting |
| Hamilton, Ontario, Canada, L8S 4K1 | |
| Principal Investigator: Salhab el Helou, MD/AssocProf | |
| 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 Respiratory Distress Syndrome, Newborn Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases |
Infant, Newborn, Diseases Pulmonary Surfactants Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013