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

Not Applicable

Completed

• Conditions: Lung Injury; Respiratory Distress Syndrome in Premature Infant; Non-invasive Ventilation
• Interventions: Procedure: openCPAP; Procedure: standardCPAP

• Registration Number: NCT05031650
• Lead Sponsor: Dokuz Eylul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
openCPAP	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.
standardCPAP	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Etlik Zubeyde Hanım Maternity and Children Hospital; 🇹🇷 Ankara, Turkey

Dokuz Eylul University; 🇹🇷 İzmir, Turkey