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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05031650
Other study ID # Dokuz Eylul Neonatology
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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