Lung Injury, Non-invasive Ventilation, Respiratory Distress Syndrome in Premature Infant
Conditions
Keywords
nasal CPAP, delivery room, open lung strategy, PEEP, Respiratory Distress Syndrome, Individualised ventilation
Brief summary
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.
Interventions
PROCEDUREopenCPAP
Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
PROCEDUREstandardCPAP
Randomized to : Standard level CPAP between 6-8 cmH2O pressure
Sponsors
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 2 Minutes
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of invasive mechanical ventilation | First 72 hours after the intervention | Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV) |
| Incidence of Surfactant therapy | First 72 hours after the intervention | Surfactant therapy requirement |
| SpO2 at 5th minute | 5 minute after the delivery | The oxygen saturation of the blood at 5 th minute |
| SpO2 at 10th minute | 5 minute after the delivery | The oxygen saturation of the blood at 10 th minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of oxygen (O2) | During hospitalisation ( an average of 10 weeks) | Duration of O2 treatment (days) |
| Incidence of Surfactant treatment | During hospitalisation (an average of 10 weeks) | Mean number of surfactant treatment |
| Incidence of pneumothorax | First 24 hours after the intervention | Incidence of pneumothorax during intervention and within 24 hours |
| Mortality | through study completion (an average of 10 weeks) | Death or composite outcome death/BPD |
| Bronchopulmonary dysplasia (BPD) | At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first | Incidence of BPD |
| Incidence ofIVH (Grade 3-4) | First 72 hours after the intervention | Intraventricular hemorrhage (IVH) |
| Duration of ventilatory support (non-invasive) | During first hospitalisation ( an average of 10 weeks) | Duration of non-invasive MV (days) |
| Duration of invasive ventilatory support | During first hospitalisation ( an average of 10 weeks) | Duration of invasive MV ( days) |
Countries
Turkey (Türkiye)
Outcome results
None listed