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

Lung Injury Clinical Trial

— OpenCPAP-DR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031650
• Other study ID #: Dokuz Eylul Neonatology
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 2 Minutes

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• openCPAP
Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
• standardCPAP
Randomized to : Standard level CPAP between 6-8 cmH2O pressure

Locations

Country	Name	City	State
Turkey	Etlik Zubeyde Hanim Maternity and Children Hospital	Ankara
Turkey	Dokuz Eylul University	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of Surfactant therapy	Surfactant therapy requirement	First 72 hours after the intervention
Primary	SpO2 at 5th minute	The oxygen saturation of the blood at 5 th minute	5 minute after the delivery
Primary	SpO2 at 10th minute	The oxygen saturation of the blood at 10 th minute	5 minute after the delivery
Secondary	Incidence of pneumothorax	Incidence of pneumothorax during intervention and within 24 hours	First 24 hours after the intervention
Secondary	Incidence ofIVH (Grade 3-4)	Intraventricular hemorrhage (IVH)	First 72 hours after the intervention
Secondary	Duration of ventilatory support (non-invasive)	Duration of non-invasive MV (days)	During first hospitalisation ( an average of 10 weeks)
Secondary	Duration of invasive ventilatory support	Duration of invasive MV ( days)	During first hospitalisation ( an average of 10 weeks)
Secondary	Duration of oxygen (O2)	Duration of O2 treatment (days)	During hospitalisation ( an average of 10 weeks)
Secondary	Incidence of Surfactant treatment	Mean number of surfactant treatment	During hospitalisation (an average of 10 weeks)
Secondary	Bronchopulmonary dysplasia (BPD)	Incidence of BPD	At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first
Secondary	Mortality	Death or composite outcome death/BPD	through study completion (an average of 10 weeks)