Clinical Trials Logo

Clinical Trial Summary

Non-invasive respiratory support methods have been widely used in premature babies with respiratory distress syndrome (RDS) which has changed the basic management of premature babies in the early period. According to the 2019 European Guidelines on RDS management, early nasal CPAP is recommended as first-line therapy in infants <30 weeks of age who are at risk of RDS who do not require mechanical ventilation (MV). However, some of the premature babies have faced non-invasive ventilation failure. Remarkably, infants who experience non-invasive ventilation failure are at increased risk of death, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia (BPD), among other morbidities. In non-invasive ventilation failure, although demographic factors such as small gestational age, low birth weight, and male gender play a role, it has been suggested that surfactant deficiency may also play an important role. The most frequently reported risk factor in predicting non-invasive failure in studies is the fraction of inspiring oxygen during the first hours of life. In addition, positive end-expiratory airway pressure (PEEP) required for patient stabilization was found to be a potential predictor. However, there are still limited data to predict non-invasive ventilation failure. "Which newborns are at high risk for non-invasive ventilation failure?" and "When should the surfactant be applied?". The study is a single-center, prospective study to evaluate prognostic factors, and most importantly to define the FiO2 threshold, which is an indicator of possible non-invasive ventilation failure in infants supported with nasal intermittent positive pressure ventilation.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05260424
Study type Observational
Source Ankara City Hospital Bilkent
Contact
Status Completed
Phase
Start date December 1, 2020
Completion date February 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01206946 - Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants Phase 2
Completed NCT00739115 - The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT01242462 - Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial Phase 1/Phase 2
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Completed NCT00486850 - Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress Phase 4
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Completed NCT05796128 - NIPPV vs.nCPAP During LISA Procedure N/A
Withdrawn NCT02835209 - Positioning During SBT in NICU Infants N/A
Terminated NCT01467076 - Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF) Phase 2
Completed NCT00556738 - Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn N/A
Completed NCT00828243 - Genetic Regulation of Surfactant Deficiency
Not yet recruiting NCT05594030 - Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Completed NCT02332304 - Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity. Phase 3
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT04137783 - ABCA3 Gene and RDS in Late Preterm and Term Infants
Completed NCT01941524 - Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations Phase 4
Completed NCT01102543 - Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS) N/A
Completed NCT00501982 - Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Phase 4