Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room

Study Overview
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Brief Summary
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The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or less is a standard treatment approach since it reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory distress syndrome (RDS) management, providing optimal lung volumes in the very early period from the beginning of delivery room approaches probably augments the expected lung protective effect. Although the benefits of CPAP support are well known, standart CPAP pressures recommended in the guidelines may not meet the needs of individual babies. Maintaining lung patency in the delivery room is the main mechanism of action of CPAP and the requirement may vary individually depending on lung physiology. In this multicenter randomized controlled study, we aimed to compare the effects of CPAP therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement in preterm babies with RDS in the delivery room.

Official Title
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Can Open Lung Strategy During Non-Invasive Respiratory Support of Very Premature Infants in the Delivery Room Reduce Non-Invasive Ventilation Failure Compared With Standard Approach? A Randomised Controlled Multicentric Trial

Conditions
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Respiratory Distress Syndrome in Premature Infant, Non-invasive Ventilation, Lung Injury

Intervention / Treatment
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* Procedure: openCPAP
* Procedure: standardCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born before 30 completed weeks of gestation and received early nCPAP immediately after birth in delivery room Exclusion Criteria: Requirement of surfactant or endotracheal intubation or positive pressure ventilation before the completion of interventions Major congenital anomaly Transportation to another hospital

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Minutes

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 |
| --- | --- |
| Active Comparator: openCPAP<br>Immediately after birth, early nCPAP will be started with a nasal mask with a T-piece resuscitator with 8 cm H2O pressure and 0.30 fiO2. The heart rate (HR) and preductal saturation (SpO2) will be evaluated every 30 seconds. Individually, the following steps will be done according to the situation: If the HR > 120 / min and SpO2 not measured yet or be in the target range: The pressure will be continue as 8 cmH2O. If the HR between 100-120 but SpO2 below the target range or not measured yet : First the pressure will be increased to 10 cm H2O; than fiO2 will be increased gradually if the patient will not respond to 10 cmH2O pressure. Pressure will be reduced to 8 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds. | Procedure: openCPAP<br>* Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure<br>|
| Active Comparator: standardCPAP<br>Immediately after birth, early nCPAP will be started with a nasal mask with T-piece resuscitator at 6 cmH2O pressure and 0.30 fiO2. HR and preductal saturation will be evaluated every 30 seconds. The following steps will be performed according to the situation: If the HR > 120 / min and SpO2 be in the target range or not measurable yet: The pressure will be continue as 6 cmH2O. If the HR between 100-120 but SpO2 below the target range or not measured yet : The pressure will increased up to 8 cm H2O. FiO2 will be increased gradually if the patient will not respond to 8 cmH2O pressure. Pressure will be reduced to 6 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds. | Procedure: standardCPAP<br>* Randomized to : Standard level CPAP between 6-8 cmH2O pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive mechanical ventilation | Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV) | First 72 hours after the intervention | 
| Incidence of Surfactant therapy | Surfactant therapy requirement | First 72 hours after the intervention | 
| SpO2 at 5th minute | The oxygen saturation of the blood at 5 th minute | 5 minute after the delivery | 
| SpO2 at 10th minute | The oxygen saturation of the blood at 10 th minute | 5 minute after the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumothorax | Incidence of pneumothorax during intervention and within 24 hours | First 24 hours after the intervention | 
| Incidence ofIVH (Grade 3-4) | Intraventricular hemorrhage (IVH) | First 72 hours after the intervention | 
| Duration of ventilatory support (non-invasive) | Duration of non-invasive MV (days) | During first hospitalisation ( an average of 10 weeks) | 
| Duration of invasive ventilatory support | Duration of invasive MV ( days) | During first hospitalisation ( an average of 10 weeks) | 
| Duration of oxygen (O2) | Duration of O2 treatment (days) | During hospitalisation ( an average of 10 weeks) | 
| Incidence of Surfactant treatment | Mean number of surfactant treatment | During hospitalisation (an average of 10 weeks) | 
| Bronchopulmonary dysplasia (BPD) | Incidence of BPD | At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first | 
| Mortality | Death or composite outcome death/BPD | through study completion (an average of 10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal CPAP, delivery room, open lung strategy, PEEP, Respiratory Distress Syndrome, Individualised ventilation