Status:
UNKNOWN
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
Lead Sponsor:
Federal University of Minas Gerais
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
30-8 years
Phase:
PHASE4
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 du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01173237
Start Date
July 1 2011
End Date
July 1 2013
Last Update
June 28 2011
Active Locations (2)
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1
Maternidade Odete Valadares
Belo Horizonte, Minas Gerais, Brazil, 30110-072
2
Hospital Dia e Maternidade Unimed-BH
Belo Horizonte, Minas Gerais, Brazil, 30431-253