Surfactant Administration During Spontaneous Breathing (TAKE CARE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01329432

First Posted: April 6, 2011

Last Update Posted: April 6, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Zekai Tahir Burak Women's Health Research and Education Hospital

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: primary spontaneous pneumothorax

Genetic and Rare Diseases Information Center resources: Bronchopulmonary Dysplasia

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 ]

Secondary Outcome Measures:

incidence of bronchopulmonary dysplasia [ Time Frame: 8-10 weeks ]


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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:

Kribs A, Härtel C, Kattner E, Vochem M, Küster H, Möller J, Müller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Göpel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.


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
First Submitted:	April 1, 2011
First Posted:	April 6, 2011
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:


Respiratory Aspiration Emphysema Bronchopulmonary Dysplasia Pneumothorax Pulmonary Emphysema Respiration Disorders Respiratory Tract Diseases Pathologic Processes Ventilator-Induced Lung Injury	Lung Injury Lung Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Pleural Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Pulmonary Surfactants Respiratory System Agents

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