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

Completed

• Conditions: Respiratory Distress Syndrome, Newborn; Premature
• Interventions: Other: non-invasive ventilation

• Registration Number: NCT05260424
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-invasive ventilation success	non-invasive ventilation	babies who will not intubated in the first 72 hours
non-invasive ventilation failure	non-invasive ventilation	babies who will be intubated in the first 72 hours

Primary Outcome Measures

Name	Time	Method
Risk of intubation in the first 72 hours in premature babies	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 Outcome Measures

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

Trial Locations

Locations (1)

Ankara City Hospital Bilkent; 🇹🇷 Ankara, Turkey