Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tracheal intubation | Active Comparator | Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use tracheal intubation for surfactant therapy | Procedure | Surfactant endotracheal administration after tracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of inspired oxygen | three hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal evaluation of pain | three hours | |
| Proseal laryngeal mask surfactant treatment failure | Six hours | |
| Rate of respiratory distress syndrome complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosilu F Barbosa, MD, MSc | Contact | 00 55 31 88144163 | rosilu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yerkes P Silva, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternidade Odete Valadares | Belo Horizonte | Minas Gerais | 30110-072 | Brazil |
Not provided
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Use of Proseal laryngeal mask airway for surfactant therapy | Procedure | Surfactant use by proseal laryngeal mask airway |
|
|
| 28 days |
| Hospital Dia e Maternidade Unimed-BH | Belo Horizonte | Minas Gerais | 30431-253 | Brazil |
|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |