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临床试验/NCT07186790
NCT07186790尚未招募不适用

Risk Factors for Initial Non Invasive Ventilation Failure in Preterms With Gestational Age <32 Weeks in Neonatal Intensive Care Units of Assiut University Children Hospital ,One Year Study

Assiut University0 个研究点目标入组 160 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
主要终点
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •The study will include neonates who meet all of the following criteria:
  • •Preterms born at a gestational age of less than 32 weeks.
  • •Birth weight less than 1,500 grams (very low birth weight).
  • •Received initial non-invasive ventilation (e.g., CPAP or HFNC) within the first hours of life.
  • •Admitted to participating NICUs during the study period.
  • •Complete medical records available for review and analysis.

排除标准

  • •Preterms will be excluded from the study if they meet any of the following conditions:
  • •Received immediate invasive mechanical ventilation at birth without a trial of non-invasive ventilation.
  • •Presence of major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations).
  • •Diagnosed with chromosomal abnormalities or genetic syndromes.
  • •Incomplete or missing medical records that prevent accurate data extraction.
  • •Preterms transferred from another hospital after initiation of respiratory support.

结局指标

主要结局

Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study

时间窗: One year

Risk factors for initial non invasive ventilation failure in preterms with gestational age \<32 weeks in neonatal intensive care units of assiut university children hospital,one year study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara mohamed hadia mohamed

Principal investigator

Assiut University

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