Surfactant Administration During Spontaneous Breathing (TAKE CARE)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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 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