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

Dokuz Eylül University (DEU)

Status: Completed

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

Treatments: Procedure: standardCPAP; Procedure: openCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT05031650

Dokuz Eylul Neonatology

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 1 to 2 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

openCPAP

Active Comparator group

Description:

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.

Treatment:

Procedure: openCPAP

standardCPAP

Active Comparator group

Description:

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.

Treatment:

Procedure: standardCPAP