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Clinical Trials/NCT05260424
NCT05260424
Completed
Not Applicable

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

Ankara City Hospital Bilkent1 site in 1 country397 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Newborn
Sponsor
Ankara City Hospital Bilkent
Enrollment
397
Locations
1
Primary Endpoint
Risk of intubation in the first 72 hours in premature babies
Status
Completed
Last Updated
5 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
February 1, 2024
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \<32 weeks preterm babies
  • Those who have received nasal intermittent positive pressure ventilation

Exclusion Criteria

  • Babies born\> 32 weeks
  • Babies with congenital anomalies
  • Babies who have intubated in the delivery room
  • Babies whose parents refuse to participitate

Outcomes

Primary Outcomes

Risk of intubation in the first 72 hours in premature babies

Time Frame: 2 year

To determine the risk of intubation in the first 72 hours of life in premature babies less than 32 weeks of gestation who have supported with nasal intermittent positive pressure ventilation

Secondary Outcomes

  • Looking for early predictors,(2 year)
  • To describe the incidence and early precursors of non-invasive ventilation failure.(2 year)
  • morbidity and mortality(2 year)

Study Sites (1)

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