NCT05031650: OpenCPAP-DR

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

Completed NA Last updated 10 May 2023

What this trial tests

NA trial testing openCPAP in Respiratory Distress Syndrome in Premature Infant in 145 participants. Completed in 1 March 2023.

Timeline

1 July 2019

Primary endpoint
31 December 2022

1 March 2023

Quick facts

Lead sponsor	Dokuz Eylul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	145
Start date	1 July 2019
Primary completion	31 December 2022
Estimated completion	1 March 2023
Sites	2 locations across Turkey (Türkiye)

Drugs / interventions tested

• openCPAP
• standardCPAP

Conditions studied

• Respiratory Distress Syndrome in Premature Infant — all drugs for Respiratory Distress Syndrome in Premature Infant →
• Non-invasive Ventilation — all drugs for Non-invasive Ventilation →
• Lung Injury — all drugs for Lung Injury →

Sponsor

Dokuz Eylul University

Who can join

Adults 1 Minute to 2 Minutes, any sex, with Respiratory Distress Syndrome in Premature Infant or Non-invasive Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-invasive open lung strategy in delivery room: randomized controlled trial (OpenCPAP-DR).
   Duman N, Durukan Tosun M, Tuzun F, Egeli T, et al · · 2025 · PMID 41247385 · DOI 10.1007/s00431-025-06613-8