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

NCT05031650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-05-10

No results posted yet for this study

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

Interventions

PROCEDURE

openCPAP

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

PROCEDURE

standardCPAP

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

Sponsors & Collaborators

  • Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

    collaborator OTHER

  • Dokuz Eylul University

    lead OTHER

Principal Investigators

  • Hasan Ozkan, Prof. · Dokuz Eylül University- Faculty of Medicine

  • Nuray Duman, Prof. · Dokuz Eylül University- Faculty of Medicine

  • Funda Tuzun, Assoc.Prof. · Dokuz Eylül University- Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
2 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-12-31
Completion
2023-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031650 on ClinicalTrials.gov