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

NCT05031650 | Completed

• 1 other identifier: Dokuz Eylul Neonatology
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

nasal CPAP; delivery room; open lung strategy; PEEP; Respiratory Distress Syndrome; Individualised ventilation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Incidence of pneumothorax

  First 24 hours after the intervention

• Incidence ofIVH (Grade 3-4)

  First 72 hours after the intervention

• Duration of ventilatory support (non-invasive)

  During first hospitalisation ( an average of 10 weeks)

• Duration of invasive ventilatory support

  During first hospitalisation ( an average of 10 weeks)

• Duration of oxygen (O2)

  During hospitalisation ( an average of 10 weeks)

Study Arms (2)

openCPAP

ACTIVE COMPARATOR

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

standardCPAP

ACTIVE COMPARATOR

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

Interventions

openCPAP PROCEDURE

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

openCPAP

standardCPAP PROCEDURE

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

standardCPAP

Eligibility Criteria

• Age: 1 Minute - 2 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born before 30 completed weeks of gestation and received early nCPAP immediately after birth in delivery room

You may not qualify if:

• Requirement of surfactant or endotracheal intubation or positive pressure ventilation before the completion of interventions
• Major congenital anomaly
• Transportation to another hospital

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: collaborator

Study Sites (2)

Etlik Zubeyde Hanım Maternity and Children Hospital

Ankara, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• Duman N, Durukan Tosun M, Tuzun F, Egeli T, Bas AY, Pamukcu MM, Deliloglu B, Akyildiz C, Armagan C, Keskinoglu P, Demirel N, Ozkan H. Non-invasive open lung strategy in delivery room: randomized controlled trial (OpenCPAP-DR). Eur J Pediatr. 2025 Nov 17;184(12):766. doi: 10.1007/s00431-025-06613-8.

  PMID: 41247385 DERIVED

MeSH Terms

Conditions

Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiration Disorders

Study Officials

• Hasan Ozkan, Prof.

  Dokuz Eylül University- Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Nuray Duman, Prof.

  Dokuz Eylül University- Faculty of Medicine

  STUDY DIRECTOR

• Funda Tuzun, Assoc.Prof.

  Dokuz Eylül University- Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 2, 2021
• Study Start: July 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)