Brief Title
Surfactant Administration During Spontaneous Breathing
Official Title
Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study
Brief Summary
Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.
Detailed Description
In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
nasal cPAP failure and need for mechanical ventilation within 72 hours
Secondary Outcome
incidence of bronchopulmonary dysplasia
Condition
Pneumothorax
Intervention
Take care
Study Arms / Comparison Groups
take care
Description: In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
December 2010
Completion Date
December 2011
Primary Completion Date
January 2011
Eligibility Criteria
Inclusion Criteria: - All infants who presented with clinical anl laboratory signs of RDS Exclusion Criteria: - infants who required intubation or PPV right after birth
Gender
All
Ages
23 Weeks - 35 Weeks
Accepts Healthy Volunteers
No
Contacts
, +90 505 588 11 89, [email protected]
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT01329432
Organization ID
2011-019
Study Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor
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Verification Date
December 2010