Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Federal University of Minas Gerais.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01173237
First received: July 26, 2010
Last updated: June 27, 2011
Last verified: July 2010

July 26, 2010
June 27, 2011
July 2011
March 2012   (final data collection date for primary outcome measure)
Fraction of inspired oxygen [ Time Frame: three hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01173237 on ClinicalTrials.gov Archive Site
  • Hormonal evaluation of pain [ Time Frame: three hours ] [ Designated as safety issue: Yes ]
  • Proseal laryngeal mask surfactant treatment failure [ Time Frame: Six hours ] [ Designated as safety issue: Yes ]
  • Rate of respiratory distress syndrome complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Distress Syndrome, Newborn
  • Procedure: Use tracheal intubation for surfactant therapy
    Surfactant endotracheal administration after tracheal intubation
    Other Name: Endotracheal tube
  • Procedure: Use of Proseal laryngeal mask airway for surfactant therapy
    Surfactant use by proseal laryngeal mask airway
    Other Name: Laryngeal mask airway
  • Active Comparator: Tracheal intubation
    Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency.
    Intervention: Procedure: Use tracheal intubation for surfactant therapy
  • Experimental: 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.
    Intervention: Procedure: Use of Proseal laryngeal mask airway for surfactant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
July 2013
March 2012   (final data collection date for primary outcome measure)

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
Both
up to 8 Hours
No
Contact: Rosilu F Barbosa, MD, MSc 00 55 31 88144163 rosilu@gmail.com
Brazil
 
NCT01173237
CAAE 00160287000-10
Yes
Rosilu Ferreira Barbosa, Federal University of Minas Gerais
Federal University of Minas Gerais
Not Provided
Principal Investigator: Yerkes P Silva, PhD Federal University of Minas Gerais
Federal University of Minas Gerais
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP