Surfactant Administration During Spontaneous Breathing (TAKE CARE)

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 4

Conditions: Pneumothorax; Bronchopulmonary Dysplasia; Pulmonary Interstitial Emphysema

Treatments: Procedure: InSurE; Procedure: Take care

Study type: Interventional

Funder types: Other

Identifiers

NCT01329432

2011-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 23 to 35 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

take care

Sham Comparator group

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

Treatment:

Procedure: Take care

InSurE

Experimental group

Description:

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

Treatment:

Procedure: InSurE