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Surfactant Administration During Spontaneous Breathing (TAKE CARE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01329432
First received: April 1, 2011
Last updated: April 5, 2011
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Pneumothorax
Pulmonary Interstitial Emphysema
Bronchopulmonary Dysplasia
 Procedure: Take care
Procedure: InSurE
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • nasal cPAP failure and need for mechanical ventilation within 72 hours [ Time Frame: first 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of bronchopulmonary dysplasia [ Time Frame: 8-10 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility
Ages Eligible for Study:   23 Weeks to 35 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329432

Contacts
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
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

Publications:

Responsible Party: Gozde Kanmaz, MD, Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit
ClinicalTrials.gov Identifier: NCT01329432     History of Changes
Other Study ID Numbers: 2011-019
Study First Received: April 1, 2011
Last Updated: April 5, 2011
Health Authority: Turkey: Ankara local ethic committee

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
surfactant
intubation
spontaneous breathing
bronchopulmonary dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Pneumothorax
Pulmonary Emphysema
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Diseases, Obstructive
Lung Injury
 Pleural Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015