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Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

This study is not yet open for participant recruitment.
Verified July 2010 by Federal University of Minas Gerais
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01173237
First received: July 26, 2010
Last updated: June 27, 2011
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
 Procedure: Use tracheal intubation for surfactant therapy
Procedure: Use of Proseal laryngeal mask airway for surfactant therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Fraction of inspired oxygen [ Time Frame: three hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hormonal evaluation of pain [ Time Frame: three hours ] [ Designated as safety issue: Yes ]
  • Proseal laryngeal mask surfactant treatment failure [ Time Frame: Six hours ] [ Designated as safety issue: Yes ]
  • Rate of respiratory distress syndrome complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tracheal intubation
Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency.
 Procedure: Use tracheal intubation for surfactant therapy
Surfactant endotracheal administration after tracheal intubation
Other Name: Endotracheal tube
Experimental: Proseal laryngeal mask airway
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.
 Procedure: Use of Proseal laryngeal mask airway for surfactant therapy
Surfactant use by proseal laryngeal mask airway
Other Name: Laryngeal mask airway

  Eligibility

Ages Eligible for Study:   up to 8 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173237

Contacts
Contact: Rosilu F Barbosa, MD, MSc 00 55 31 88144163 rosilu@gmail.com

Locations
Brazil
Hospital Dia e Maternidade Unimed-BH Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30431-253
Contact: Rosilu F Barbosa, MD, MSc     00 55 31 88144163     rosilu@gmail.com    
Principal Investigator: Yerkes P Silva, MD. MSc, PhD            
Maternidade Odete Valadares Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30110-072
Contact: Rosilu F Barbosa, MD, MSc     00 55 31 88144163     rosilu@gmail.com    
Principal Investigator: Yerkes P Silva, MD, MSc, PhD            
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Yerkes P Silva, PhD Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Rosilu Ferreira Barbosa, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01173237     History of Changes
Other Study ID Numbers: CAAE 00160287000-10
Study First Received: July 26, 2010
Last Updated: June 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
tracheal intubation
proseal laryngeal mask airway
neonate
surfactant
respiratory distress syndrome

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
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