Respiratory Distress Syndrome, Newborn
Conditions
Keywords
tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome
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.
Interventions
PROCEDUREUse tracheal intubation for surfactant therapy
Surfactant endotracheal administration after tracheal intubation
PROCEDUREUse of Proseal laryngeal mask airway for surfactant therapy
Surfactant use by proseal laryngeal mask airway
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 8 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of inspired oxygen | three hours |
Secondary
| Measure | Time frame |
|---|---|
| Hormonal evaluation of pain | three hours |
| Proseal laryngeal mask surfactant treatment failure | Six hours |
| Rate of respiratory distress syndrome complications | 28 days |
Countries
Brazil
Contacts
Primary ContactRosilu F Barbosa, MD, MSc
Outcome results
None listed