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Surfactant Administration During Spontaneous Breathing (TAKE CARE)

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ClinicalTrials.gov Identifier: NCT01329432
Recruitment Status : Unknown
Verified December 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumothorax Pulmonary Interstitial Emphysema Bronchopulmonary Dysplasia Procedure: Take care Procedure: InSurE Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study
Study Start Date : December 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: take care
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
 Procedure: Take care
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.
Experimental: InSurE
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration
 Procedure: InSurE
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.


Outcome Measures
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Primary Outcome Measures :
  1. nasal cPAP failure and need for mechanical ventilation within 72 hours [ Time Frame: first 72 hours ]

Secondary Outcome Measures :
  1. incidence of bronchopulmonary dysplasia [ Time Frame: 8-10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   23 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329432


Contacts
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Contact: Gozde Kanmaz, MD +90 505 588 11 89 gzdekanmaz@yahoo.com
Contact: Omer Erdeve, MD +90 312 306 56 76 omererdeve@yahoo.com

Locations
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Turkey
Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit Recruiting
Ankara, Turkey, 06100
Contact: Gozde Kanmaz, MD    + 90 505 588 11 89    gzdekanmaz@yahoo.com   
Contact: Omer Erdeve, MD    +90 312 306 56 76    omererdeve@yahoo.com   
Principal Investigator: Gozde Kanmaz, MD         
Sub-Investigator: Banu Mutlu, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
More Information
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Publications of Results:

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Responsible Party: Gozde Kanmaz, MD, Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit
ClinicalTrials.gov Identifier: NCT01329432    
Other Study ID Numbers: 2011-019
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: December 2010
Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
surfactant
intubation
spontaneous breathing
bronchopulmonary dysplasia
Additional relevant MeSH terms:
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Respiratory Aspiration
Bronchopulmonary Dysplasia
Pneumothorax
Emphysema
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
 Lung Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pleural Diseases