Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Procedure: Use tracheal intubation for surfactant therapy; Procedure: Use of Proseal laryngeal mask airway for surfactant therapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rosilu F Barbosa, MD, MSc; Phone Number: 00 55 31 88144163; Email: rosilu@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-072
      • Maternidade Odete Valadares
      • Contact: Rosilu F Barbosa, MD, MSc; Phone Number: 00 55 31 88144163; Email: rosilu@gmail.com
      • Principal Investigator: Yerkes P Silva, MD, MSc, PhD
    • Belo Horizonte, Minas Gerais, Brazil, 30431-253
      • Hospital Dia e Maternidade Unimed-BH
      • Contact: Rosilu F Barbosa, MD, MSc; Phone Number: 00 55 31 88144163; Email: rosilu@gmail.com
      • Principal Investigator: Yerkes P Silva, MD. MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 8 hours (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fraction of inspired oxygen	three hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Hormonal evaluation of pain	three hours
Proseal laryngeal mask surfactant treatment failure	Six hours
Rate of respiratory distress syndrome complications	28 days

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): March 1, 2012
• Study Completion (ANTICIPATED): July 1, 2013

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (ESTIMATE): August 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: neonate; respiratory distress syndrome; surfactant; tracheal intubation; proseal laryngeal mask airway
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: CAAE 00160287000-10