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

NCT01615016 | Terminated Phase 2 DMC

• 1 other identifier: NIF-12295
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyaline Membrane Disease

Keywords

Preterm infant; Surfactant application; Respiratory Distress Syndrome; Minimally invasive Surfactant Application; INSURE (Intubate-Surfactant-Extubate)

Outcome Measures

Primary Outcomes (1)

• Proportion of included infants who were treated according to protocol

  Feasibility criteria endpoint after 12 months

Secondary Outcomes (1)

• Recruitment rate

  1 year.

Study Arms (2)

MISurf

EXPERIMENTAL

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

InSurE

ACTIVE COMPARATOR

Surfactant application via Intubation - Surfactant Application - Extubation sequence

Other: Minimally invasive endotracheal surfactant application

Interventions

Minimally invasive endotracheal surfactant application OTHER

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

Also known as: Surfactant Application via feeding tube., Non invasive surfactant application.

InSurE; MISurf

Eligibility Criteria

• Age: Up to 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster University Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Hyaline Membrane Disease; Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Salhab el Helou, MD/AssocProf

  McMaster University Children's Hospital/Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Intervention team whose members are not part of the patients' care team. Blinded for type of intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. / Associate Professor

Model Details: Randomized, double blind

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 8, 2012
• Study Start: July 1, 2012
• Primary Completion: August 19, 2017
• Study Completion: August 19, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

CA (1)