Surfactant Administration During Spontaneous Breathing

NCT01329432 | Unknown Phase 4

• 1 other identifier: 2011-019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax; Pulmonary Interstitial Emphysema; Bronchopulmonary Dysplasia

Keywords

surfactant; intubation; spontaneous breathing; bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• nasal cPAP failure and need for mechanical ventilation within 72 hours

  first 72 hours

Secondary Outcomes (1)

• incidence of bronchopulmonary dysplasia

  8-10 weeks

Study Arms (2)

take care

SHAM COMPARATOR

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

InSurE

EXPERIMENTAL

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

Procedure: InSurE

Interventions

Take care PROCEDURE

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.

take care

InSurE PROCEDURE

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

InSurE

Eligibility Criteria

• Age: 23 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• infants who required intubation or PPV right after birth

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 20084586 RESULT

MeSH Terms

Conditions

Pneumothorax; Mediastinal Emphysema; Bronchopulmonary Dysplasia

Interventions

Insure Cement

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Gozde Kanmaz, MD

CONTACT

+90 505 588 11 89; gzdekanmaz@yahoo.com

Omer Erdeve, MD

CONTACT

+90 312 306 56 76; omererdeve@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 6, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 6, 2011

Record last verified: 2010-12

Locations

TU (1)