NCT05031650

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 1 Minute – 2 Minutes
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	openCPAP	Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
PROCEDURE	standardCPAP	Randomized to : Standard level CPAP between 6-8 cmH2O pressure

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-12-31
• Completion: 2023-03-01
• First posted: 2021-09-02
• Last updated: 2023-05-10

Locations

2 sites across 1 country: Turkey (Türkiye)