Surfactant Administration During Spontaneous Breathing

Bronchopulmonary Dysplasia Clinical Trial

— TAKE CARE  

Official title:

Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329432
• Other study ID #: 2011-019
• Status: Recruiting
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: April 5, 2011
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Gozde Kanmaz, MD
• Phone: +90 505 588 11 89
• Email: gzdekanmaz[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ankara local ethic committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 35 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• infants who required intubation or PPV right after birth

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Pneumothorax
• Pulmonary Emphysema
• Pulmonary Interstitial Emphysema

Intervention

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

Locations

Country	Name	City	State
Turkey	Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Kli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nasal cPAP failure and need for mechanical ventilation within 72 hours		first 72 hours	No
Secondary	incidence of bronchopulmonary dysplasia		8-10 weeks	No