Surfactant Administration During Spontaneous Breathing

Phase 4

• Conditions: Pneumothorax; Pulmonary Interstitial Emphysema; Bronchopulmonary Dysplasia
• Interventions: Procedure: Take care; Procedure: InSurE

• Registration Number: NCT01329432
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Primary Completion: 2011-01
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Last Update Submitted: 2011-04-05
• Study First Posted: 2011-04-06
• Last Update Posted: 2011-04-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
take care	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	InSurE	infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration

Primary Outcome Measures

Name	Time	Method
nasal cPAP failure and need for mechanical ventilation within 72 hours	first 72 hours

Secondary Outcome Measures

Name	Time	Method
incidence of bronchopulmonary dysplasia	8-10 weeks

Trial Locations

Locations (1)

Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit; 🇹🇷 Ankara, Turkey