Surfactant Administration During Spontaneous Breathing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumothorax, Pulmonary Interstitial Emphysema, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Procedure: Take care
* Procedure: InSurE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants who presented with clinical anl laboratory signs of RDS Exclusion Criteria: infants who required intubation or PPV right after birth

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: take care<br>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<br>* 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.<br>|
| Experimental: InSurE<br>infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration | Procedure: InSurE<br>* infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal cPAP failure and need for mechanical ventilation within 72 hours |  | first 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bronchopulmonary dysplasia |  | 8-10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surfactant, intubation, spontaneous breathing, bronchopulmonary dysplasia