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Surfactant Administration During Spontaneous Breathing (TAKE CARE)

Primary Purpose

Pneumothorax, Pulmonary Interstitial Emphysema, Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Take care
InSurE
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring surfactant, intubation, spontaneous breathing, bronchopulmonary dysplasia

Eligibility Criteria

23 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All infants who presented with clinical anl laboratory signs of RDS

Exclusion Criteria:

  • infants who required intubation or PPV right after birth

Sites / Locations

  • Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

take care

InSurE

Arm 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

infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration

Outcomes

Primary Outcome Measures

nasal cPAP failure and need for mechanical ventilation within 72 hours

Secondary Outcome Measures

incidence of bronchopulmonary dysplasia

Full Information

First Posted
April 1, 2011
Last Updated
April 5, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01329432
Brief Title
Surfactant Administration During Spontaneous Breathing
Acronym
TAKE CARE
Official Title
Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Pulmonary Interstitial Emphysema, Bronchopulmonary Dysplasia
Keywords
surfactant, intubation, spontaneous breathing, bronchopulmonary dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
take care
Arm Type
Sham Comparator
Arm 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
Arm Title
InSurE
Arm Type
Experimental
Arm Description
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration
Intervention Type
Procedure
Intervention Name(s)
Take care
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
InSurE
Intervention Description
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.
Primary Outcome Measure Information:
Title
nasal cPAP failure and need for mechanical ventilation within 72 hours
Time Frame
first 72 hours
Secondary Outcome Measure Information:
Title
incidence of bronchopulmonary dysplasia
Time Frame
8-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gozde Kanmaz, MD
Phone
+90 505 588 11 89
Email
gzdekanmaz@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Erdeve, MD
Phone
+90 312 306 56 76
Email
omererdeve@yahoo.com
Facility Information:
Facility Name
Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gozde Kanmaz, MD
Phone
+ 90 505 588 11 89
Email
gzdekanmaz@yahoo.com
First Name & Middle Initial & Last Name & Degree
Omer Erdeve, MD
Phone
+90 312 306 56 76
Email
omererdeve@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gozde Kanmaz, MD
First Name & Middle Initial & Last Name & Degree
Banu Mutlu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20084586
Citation
Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel 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.
Results Reference
result

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Surfactant Administration During Spontaneous Breathing

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