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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress Syndrome, Newborn, Premature

Intervention / Treatment
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* Other: non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-invasive ventilation failure<br>babies who will be intubated in the first 72 hours | Other: non-invasive ventilation<br>* Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.<br>|
| non-invasive ventilation success<br>babies who will not intubated in the first 72 hours | Other: non-invasive ventilation<br>* Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of intubation in the first 72 hours in premature babies | 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 | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the incidence and early precursors of non-invasive ventilation failure. | Invasive, non-invasive ventilation and supplemental oxygen day time | 2 year | 
| Looking for early predictors, | Looking for early predictors, including combinations of breathed oxygen fraction (FiO2) and non-invasive ventilation level in early life | 2 year | 
| morbidity and mortality | To investigate the negative consequences of non-invasive ventilation failure. | 2 year |