Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Federal University of Minas Gerais

Status and phase: Unknown; Phase 4

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Use of Proseal laryngeal mask airway for surfactant therapy; Procedure: Use tracheal intubation for surfactant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01173237

CAAE 00160287000-10

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 minutes to 8 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tracheal intubation

Active Comparator group

Description:

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

Treatment:

Procedure: Use tracheal intubation for surfactant therapy

Proseal laryngeal mask airway

Experimental group

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.

Treatment:

Procedure: Use of Proseal laryngeal mask airway for surfactant therapy