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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
Randomized to : Standard level CPAP between 6-8 cmH2O pressure
Etlik Zubeyde Hanım Maternity and Children Hospital
Ankara, Turkey (Türkiye)
Dokuz Eylul University
Izmir, Turkey (Türkiye)
Incidence of invasive mechanical ventilation
Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV)
Time frame: First 72 hours after the intervention
Incidence of Surfactant therapy
Surfactant therapy requirement
Time frame: First 72 hours after the intervention
SpO2 at 5th minute
The oxygen saturation of the blood at 5 th minute
Time frame: 5 minute after the delivery
SpO2 at 10th minute
The oxygen saturation of the blood at 10 th minute
Time frame: 5 minute after the delivery
Incidence of pneumothorax
Incidence of pneumothorax during intervention and within 24 hours
Time frame: First 24 hours after the intervention
Incidence ofIVH (Grade 3-4)
Intraventricular hemorrhage (IVH)
Time frame: First 72 hours after the intervention
Duration of ventilatory support (non-invasive)
Duration of non-invasive MV (days)
Time frame: During first hospitalisation ( an average of 10 weeks)
Duration of invasive ventilatory support
Duration of invasive MV ( days)
Time frame: During first hospitalisation ( an average of 10 weeks)
Duration of oxygen (O2)
Duration of O2 treatment (days)
Time frame: During hospitalisation ( an average of 10 weeks)
Incidence of Surfactant treatment
Mean number of surfactant treatment
Time frame: During hospitalisation (an average of 10 weeks)
Bronchopulmonary dysplasia (BPD)
Incidence of BPD
Time frame: At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first
Mortality
Death or composite outcome death/BPD
Time frame: through study completion (an average of 10 weeks)
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