Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tracheal intubation

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

Group Type ACTIVE_COMPARATOR

Use tracheal intubation for surfactant therapy

Intervention Type PROCEDURE

Surfactant endotracheal administration after tracheal intubation

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.

Group Type EXPERIMENTAL

Use of Proseal laryngeal mask airway for surfactant therapy

Intervention Type PROCEDURE

Surfactant use by proseal laryngeal mask airway

Interventions

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Use tracheal intubation for surfactant therapy

Surfactant endotracheal administration after tracheal intubation

Intervention Type PROCEDURE

Use of Proseal laryngeal mask airway for surfactant therapy

Surfactant use by proseal laryngeal mask airway

Intervention Type PROCEDURE

Other Intervention Names

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Endotracheal tube Laryngeal mask airway

Eligibility Criteria

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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

Minimum Eligible Age

30 Minutes

Maximum Eligible Age

8 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No