Non-invasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-10-01

Brief Summary

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Risk factors for non invasive ventilation failure in preterms that lead them to use invasive ventilation

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Detailed Description

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Non-invasive ventilation (NIV) is widely utilized in the initial respiratory management of very low birth weight (VLBW) preterms , particularly those born at a gestational age of less than 32 weeks, to avoid complications associated with invasive mechanical ventilation. Despite advances in neonatal respiratory care, the risk of initial NIV failure remains a significant clinical concern due to its association with increased morbidity and the subsequent need for intubation and invasive support. Early identification of neonates at high risk for NIV failure is crucial for timely intervention and optimization of respiratory strategies to improve outcomes (Wu et al., 2024).

Previous multicenter and prospective studies have highlighted various clinical and physiological parameters contributing to the failure of NIV in preterms. These include lower gestational age, severe respiratory distress syndrome (RDS), higher oxygen requirements, and hemodynamic instability in the immediate postnatal period (Boix et al., 2023). The complexity of respiratory adaptation in this population necessitates robust risk stratification tools and predictive models to support clinical decision-making in the neonatal intensive care unit (NICU) (Fernandez-Gonzalez et al., 2022).

Recent research efforts, including the establishment of predictive models, have focused on incorporating variables such as Apgar scores, initial FiO₂, surfactant administration, and radiographic findings to identify preterms most likely to fail NIV. Understanding these risk factors is essential not only for improving survival but also for reducing the incidence of bronchopulmonary dysplasia (BPD) and other long-term pulmonary complications (Shen et al., 2024).

Furthermore, expert consensus guidelines from neonatology societies advocate for early use of continuous positive airway pressure (CPAP) and targeted surfactant therapy to mitigate the progression of RDS and enhance NIV success. However, despite adherence to best practices, a considerable proportion of VLBW preterms still experience respiratory deterioration necessitating escalation to invasive ventilation (Akin et al., 2025).

Emerging data also point to institution-specific practices, such as type of NIV modality used (e.g., nasal intermittent positive pressure ventilation vs. high-frequency oscillatory NIV) (Wang et al., 2025).

Given the significant clinical implications, understanding and applying these risk factors can help neonatal teams anticipate NIV failure early, apply targeted respiratory strategies, and improve short- and long-term outcomes in preterms (Afzal et al., 2024; de Souza Júnior et al., 2023; Yazici et al., 2025).

Conditions

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Non Invasive Ventilation Failure in Preterms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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The study will include neonates who meet all of the following criteria:

1. Preterms born at a gestational age of less than 32 weeks.
2. Birth weight less than 1,500 grams (very low birth weight).
3. Received initial non-invasive ventilation (e.g., CPAP or HFNC) within the first hours of life.
4. Admitted to participating NICUs during the study period.
5. Complete medical records available for review and analysis.

Exclusion Criteria

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Preterms will be excluded from the study if they meet any of the following conditions:

1. Received immediate invasive mechanical ventilation at birth without a trial of non-invasive ventilation.
2. Presence of major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations).
3. Diagnosed with chromosomal abnormalities or genetic syndromes.
4. Incomplete or missing medical records that prevent accurate data extraction.
5. Preterms transferred from another hospital after initiation of respiratory support.

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No