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Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Use tracheal intubation for surfactant therapy
Use of Proseal laryngeal mask airway for surfactant therapy
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome

Eligibility Criteria

30 Minutes - 8 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birthweight more than 1000 grams
  • Gestational age more than 28 weeks and less than 35 weeks
  • Chronologic age less than 8 hours
  • Diagnosis of RDS by clinical and radiographic criteria
  • Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
  • Parental consent

Exclusion Criteria:

  • Birthweight less than 1000 grams
  • Gestational age more than 28 weeks and less than 35 weeks
  • Chronologic age more than 8 hours
  • Maternal fever or premature rupture of fetal membranes less than 18 hours
  • Diagnosis other than respiratory distress syndrome
  • Babies who require or have already had endotracheal intubation
  • Analgesia and or sedation during the first six hours of life
  • Apgar 5 minute score less than three
  • Babies with congenital anomalies or signs of acute circulatory failure

Sites / Locations

  • Maternidade Odete Valadares
  • Hospital Dia e Maternidade Unimed-BH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tracheal intubation

Proseal laryngeal mask airway

Arm Description

Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency.

Laryngeal mask airway is a airway device used for ventilation with self-inflating bag or flow-inflating bag. In this study it will be used for surfactant administration, in preterm babies with SDR surfactant deficiency.

Outcomes

Primary Outcome Measures

Fraction of inspired oxygen

Secondary Outcome Measures

Hormonal evaluation of pain
Proseal laryngeal mask surfactant treatment failure
Rate of respiratory distress syndrome complications

Full Information

First Posted
July 26, 2010
Last Updated
June 27, 2011
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01173237
Brief Title
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
Official Title
Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tracheal intubation
Arm Type
Active Comparator
Arm Description
Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency.
Arm Title
Proseal laryngeal mask airway
Arm Type
Experimental
Arm Description
Laryngeal mask airway is a airway device used for ventilation with self-inflating bag or flow-inflating bag. In this study it will be used for surfactant administration, in preterm babies with SDR surfactant deficiency.
Intervention Type
Procedure
Intervention Name(s)
Use tracheal intubation for surfactant therapy
Other Intervention Name(s)
Endotracheal tube
Intervention Description
Surfactant endotracheal administration after tracheal intubation
Intervention Type
Procedure
Intervention Name(s)
Use of Proseal laryngeal mask airway for surfactant therapy
Other Intervention Name(s)
Laryngeal mask airway
Intervention Description
Surfactant use by proseal laryngeal mask airway
Primary Outcome Measure Information:
Title
Fraction of inspired oxygen
Time Frame
three hours
Secondary Outcome Measure Information:
Title
Hormonal evaluation of pain
Time Frame
three hours
Title
Proseal laryngeal mask surfactant treatment failure
Time Frame
Six hours
Title
Rate of respiratory distress syndrome complications
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
8 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birthweight more than 1000 grams Gestational age more than 28 weeks and less than 35 weeks Chronologic age less than 8 hours Diagnosis of RDS by clinical and radiographic criteria Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30% Parental consent Exclusion Criteria: Birthweight less than 1000 grams Gestational age more than 28 weeks and less than 35 weeks Chronologic age more than 8 hours Maternal fever or premature rupture of fetal membranes less than 18 hours Diagnosis other than respiratory distress syndrome Babies who require or have already had endotracheal intubation Analgesia and or sedation during the first six hours of life Apgar 5 minute score less than three Babies with congenital anomalies or signs of acute circulatory failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosilu F Barbosa, MD, MSc
Phone
00 55 31 88144163
Email
rosilu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternidade Odete Valadares
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-072
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosilu F Barbosa, MD, MSc
Phone
00 55 31 88144163
Email
rosilu@gmail.com
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, MD, MSc, PhD
Facility Name
Hospital Dia e Maternidade Unimed-BH
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30431-253
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosilu F Barbosa, MD, MSc
Phone
00 55 31 88144163
Email
rosilu@gmail.com
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, MD. MSc, PhD

12. IPD Sharing Statement

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Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

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