Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01173237
• Other study ID #: CAAE 00160287000-10
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 26, 2010
• Last updated: June 27, 2011
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2010
• Source: Federal University of Minas Gerais
• Contact: Rosilu F Barbosa, MD, MSc
• Phone: 00 55 31 88144163
• Email: rosilu[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Use tracheal intubation for surfactant therapy
Surfactant endotracheal administration after tracheal intubation
• Use of Proseal laryngeal mask airway for surfactant therapy
Surfactant use by proseal laryngeal mask airway

Locations

Country	Name	City	State
Brazil	Hospital Dia e Maternidade Unimed-BH	Belo Horizonte	Minas Gerais
Brazil	Maternidade Odete Valadares	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of inspired oxygen		three hours	Yes
Secondary	Hormonal evaluation of pain		three hours	Yes
Secondary	Proseal laryngeal mask surfactant treatment failure		Six hours	Yes
Secondary	Rate of respiratory distress syndrome complications		28 days	Yes