Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Phase 4

• Conditions: Respiratory Distress Syndrome, Newborn
• Interventions: Procedure: Use tracheal intubation for surfactant therapy; Procedure: Use of Proseal laryngeal mask airway for surfactant therapy

• Registration Number: NCT01173237
• Lead Sponsor: Federal University of Minas Gerais

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-30
• Study First Posted: 2010-08-02
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28
• Study Start: 2011-07
• Primary Completion: 2012-03
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tracheal intubation	Use tracheal intubation for surfactant therapy	Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency.
Proseal laryngeal mask airway	Use of Proseal laryngeal mask airway for surfactant therapy	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.

Primary Outcome Measures

Name	Time	Method
Fraction of inspired oxygen	three hours

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Maternidade Odete Valadares; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Dia e Maternidade Unimed-BH; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil