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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

NCT05260424

Respiratory Distress Syndrome, Newborn Premature

COMPLETED

Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome

NCT03400670

Ventilatory Failure

UNKNOWN NA

Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants

NCT07045402

Infant, Premature Kangaroo Mother Care Comfort +3 more

RECRUITING NA

NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation

NCT02842190

Intubation Complication PreTerm Birth

UNKNOWN NA

NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome

NCT02901652

Prematurity Respiratory Distress Syndrome

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

openCPAP

Intervention Type PROCEDURE

Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure

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.

Group Type ACTIVE_COMPARATOR

standardCPAP

Intervention Type PROCEDURE

Randomized to : Standard level CPAP between 6-8 cmH2O pressure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

openCPAP

Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure

Intervention Type PROCEDURE

standardCPAP

Randomized to : Standard level CPAP between 6-8 cmH2O pressure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No