Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

NCT01173237 | Unknown Phase 4 DMC

• 1 other identifier: CAAE 00160287000-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

tracheal intubation; proseal laryngeal mask airway; neonate; surfactant; respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Fraction of inspired oxygen

  three hours

Secondary Outcomes (3)

• Hormonal evaluation of pain

  three hours

• Proseal laryngeal mask surfactant treatment failure

  Six hours

• Rate of respiratory distress syndrome complications

  28 days

Study Arms (2)

Tracheal intubation

ACTIVE COMPARATOR

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

Proseal laryngeal mask airway

EXPERIMENTAL

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

Interventions

Use tracheal intubation for surfactant therapy PROCEDURE

Surfactant endotracheal administration after tracheal intubation

Also known as: Endotracheal tube

Tracheal intubation

Use of Proseal laryngeal mask airway for surfactant therapy PROCEDURE

Surfactant use by proseal laryngeal mask airway

Also known as: Laryngeal mask airway

Proseal laryngeal mask airway

Eligibility Criteria

• Age: 30 Minutes - 8 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (2)

Maternidade Odete Valadares

Belo Horizonte, Minas Gerais, 30110-072, Brazil

Location

Hospital Dia e Maternidade Unimed-BH

Belo Horizonte, Minas Gerais, 30431-253, Brazil

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Yerkes P Silva, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosilu F Barbosa, MD, MSc

CONTACT

00 55 31 88144163; rosilu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2013
• Last Updated: June 28, 2011

Record last verified: 2010-07

Locations

BR (2)