Clinical trial NCT05031650: Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infant
Non-invasive Ventilation
Lung Injury
Keywords: nasal CPAP
delivery room
open lung strategy
PEEP
Respiratory Distress Syndrome
Individualised ventilation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
First posted: 2021-09-02
Enrollment: 145
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of invasive mechanical ventilation
timeFrame: First 72 hours after the intervention
measure: Incidence of Surfactant therapy
timeFrame: First 72 hours after the intervention
measure: SpO2 at 5th minute
timeFrame: 5 minute after the delivery
measure: SpO2 at 10th minute
timeFrame: 5 minute after the delivery
Secondary outcomes:
measure: Incidence of pneumothorax
timeFrame: First 24 hours after the intervention
measure: Incidence ofIVH (Grade 3-4)
timeFrame: First 72 hours after the intervention
measure: Duration of ventilatory support (non-invasive)
timeFrame: During first hospitalisation ( an average of 10 weeks)
measure: Duration of invasive ventilatory support
timeFrame: During first hospitalisation ( an average of 10 weeks)
measure: Duration of oxygen (O2)
timeFrame: During hospitalisation ( an average of 10 weeks)
measure: Incidence of Surfactant treatment
timeFrame: During hospitalisation (an average of 10 weeks)
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first
measure: Mortality
timeFrame: through study completion (an average of 10 weeks)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zubeyde Hanım Maternity and Children Hospital
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylül University- Faculty of Medicine
name: Hasan Ozkan, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylül University- Faculty of Medicine
name: Nuray Duman, Prof.
role: STUDY_DIRECTOR
affiliation: Dokuz Eylül University- Faculty of Medicine
name: Funda Tuzun, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: