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Respiratory Distress Syndrome in Premature InfantOpenCPAP-DRNCT05031650

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

A study testing openCPAP and standardCPAP in people with Respiratory Distress Syndrome in Premature Infant and Non-invasive Ventilation, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 1 minute to 2 minutes
What is being tested?
openCPAP and standardCPAP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jul 2019to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 2 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Etlik Zubeyde Hanım Maternity and Children Hospital

    Ankara

  • Dokuz Eylul University

    Izmir, 35340

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
openCPAP, standardCPAP
Keywords
nasal CPAP, delivery room, open lung strategy, PEEP, Respiratory Distress Syndrome, Individualised ventilation
Medical subject headings
Lung Injury, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • openCPAPProcedure or surgery

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

  • standardCPAPProcedure or surgery

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

Study groups in NCT05031650
Study groupRoleWhat they receive
openCPAPActive comparatorImmediately 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.
Receives: Procedure: openCPAP
standardCPAPActive comparatorImmediately 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.
Receives: Procedure: standardCPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of invasive mechanical ventilation

    Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV)

    Measured: First 72 hours after the intervention

  2. Incidence of Surfactant therapy

    Surfactant therapy requirement

    Measured: First 72 hours after the intervention

  3. SpO2 at 5th minute

    The oxygen saturation of the blood at 5 th minute

    Measured: 5 minute after the delivery

  4. SpO2 at 10th minute

    The oxygen saturation of the blood at 10 th minute

    Measured: 5 minute after the delivery

Secondary outcomes (8)

  1. Incidence of pneumothorax

    Incidence of pneumothorax during intervention and within 24 hours

    Measured: First 24 hours after the intervention

  2. Incidence ofIVH (Grade 3-4)

    Intraventricular hemorrhage (IVH)

    Measured: First 72 hours after the intervention

  3. Duration of ventilatory support (non-invasive)

    Duration of non-invasive MV (days)

    Measured: During first hospitalisation ( an average of 10 weeks)

  4. Duration of invasive ventilatory support

    Duration of invasive MV ( days)

    Measured: During first hospitalisation ( an average of 10 weeks)

  5. Duration of oxygen (O2)

    Duration of O2 treatment (days)

    Measured: During hospitalisation ( an average of 10 weeks)

  6. Incidence of Surfactant treatment

    Mean number of surfactant treatment

    Measured: During hospitalisation (an average of 10 weeks)

  7. Bronchopulmonary dysplasia (BPD)

    Incidence of BPD

    Measured: At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first

  8. Mortality

    Death or composite outcome death/BPD

    Measured: through study completion (an average of 10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2022
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05031650
Sponsor's protocol ID
Dokuz Eylul Neonatology
Acronym
OpenCPAP-DR
Status last verified
May 2023
First submitted
17 Aug 2021
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41247385

Questions about this trial

What is this clinical trial studying?

A study testing openCPAP and standardCPAP in people with Respiratory Distress Syndrome in Premature Infant and Non-invasive Ventilation, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of invasive mechanical ventilation (time frame: First 72 hours after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05031650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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