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

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

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 Overview

• Status: Completed
• Conditions: Lung Injury; Respiratory Distress Syndrome in Premature Infant; Non-invasive Ventilation
• Intervention / Treatment: Procedure: openCPAP; Procedure: standardCPAP

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuray Duman, Prof.; Phone Number: 90 4121220; Email: nduman68@gmail.com
• Study Contact Backup: Name: Funda Tuzun, Assoc. Prof.; Phone Number: 90 4126269; Email: fundatuzun@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Etlik Zubeyde Hanım Maternity and Children Hospital
  • İzmir, Turkey, 35340
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 minutes (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: openCPAP; Immediately after birth, early nCPAP will be started with a nasal mask with a T-piece resuscitator with 8 cm H2O pressure and 0.30 fiO2. The heart rate (HR) and preductal saturation (SpO2) will be evaluated every 30 seconds. Individually, the following steps will be done according to the situation: If the HR > 120 / min and SpO2 not measured yet or be in the target range: The pressure will be continue as 8 cmH2O.; If the HR between 100-120 but SpO2 below the target range or not measured yet : First the pressure will be increased to 10 cm H2O; than fiO2 will be increased gradually if the patient will not respond to 10 cmH2O pressure. Pressure will be reduced to 8 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds.	Procedure: openCPAP; Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
Active Comparator: standardCPAP; Immediately after birth, early nCPAP will be started with a nasal mask with T-piece resuscitator at 6 cmH2O pressure and 0.30 fiO2. HR and preductal saturation will be evaluated every 30 seconds. The following steps will be performed according to the situation: If the HR > 120 / min and SpO2 be in the target range or not measurable yet: The pressure will be continue as 6 cmH2O.; If the HR between 100-120 but SpO2 below the target range or not measured yet : The pressure will increased up to 8 cm H2O. FiO2 will be increased gradually if the patient will not respond to 8 cmH2O pressure. Pressure will be reduced to 6 cmH2O if the HR remains> 120 / min and oxygen requirement <0.30 for more than 60 seconds.	Procedure: standardCPAP; Randomized to : Standard level CPAP between 6-8 cmH2O pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of invasive mechanical ventilation	Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV)	First 72 hours after the intervention
Incidence of Surfactant therapy	Surfactant therapy requirement	First 72 hours after the intervention
SpO2 at 5th minute	The oxygen saturation of the blood at 5 th minute	5 minute after the delivery
SpO2 at 10th minute	The oxygen saturation of the blood at 10 th minute	5 minute after the delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pneumothorax	Incidence of pneumothorax during intervention and within 24 hours	First 24 hours after the intervention
Incidence ofIVH (Grade 3-4)	Intraventricular hemorrhage (IVH)	First 72 hours after the intervention
Duration of ventilatory support (non-invasive)	Duration of non-invasive MV (days)	During first hospitalisation ( an average of 10 weeks)
Duration of invasive ventilatory support	Duration of invasive MV ( days)	During first hospitalisation ( an average of 10 weeks)
Duration of oxygen (O2)	Duration of O2 treatment (days)	During hospitalisation ( an average of 10 weeks)
Incidence of Surfactant treatment	Mean number of surfactant treatment	During hospitalisation (an average of 10 weeks)
Bronchopulmonary dysplasia (BPD)	Incidence of BPD	At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first
Mortality	Death or composite outcome death/BPD	through study completion (an average of 10 weeks)

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Investigators: Study Director: Nuray Duman, Prof., Dokuz Eylül University- Faculty of Medicine; Principal Investigator: Funda Tuzun, Assoc.Prof., Dokuz Eylül University- Faculty of Medicine; Principal Investigator: Hasan Ozkan, Prof., Dokuz Eylül University- Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PEEP; Respiratory Distress Syndrome; delivery room; nasal CPAP; open lung strategy; Individualised ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Thoracic Injuries; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury
• Other Study ID Numbers: Dokuz Eylul Neonatology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No