Surfactant Administration During Spontaneous Breathing

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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

, , 


Verification Date

December 2010