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临床试验/CTRI/2024/04/066151
CTRI/2024/04/066151尚未招募不适用

Incidence , Risk factors for Failure of non-invasive intermittent positive pressure ventilation in preterm infants with respiratory distress syndrome in level III NICU – a prospective observational study

Dr Sonali Amol Avale1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To study incidence, risk factors of noninvasive intermittent positive pressure ventilation (NIPPV) failure, defined as the need for intubation within 72 hours of life

研究概览

简要总结

RDS is a common cause of morbidity and mortality in preterm infants, with  severe diseases in smaller and more premature neonates. The objective of respiratory management of preterm infants with  risk of RDS is to maximize survival while minimizing potential adverse effects, such as bronchopulmonary dysplasia (BPD). The 2019 European Consensus Guidelines on the management of RDS recommend the early use of continuous positive airway pressure (CPAP) of at least 6 cm H2O in all babies at risk of RDS who do not need intubation for delivery room stabilization . Early initiation of CPAP potentially reduces the need for mechanical ventilation and surfactant replacement while improving clinical outcomes. RDS management has evolved dramatically over the last decade, almost half of the infants who are started on CPAP fail this therapy and are ultimately intubated . It should be noted that CPAP failure is associated with an increased risk of death and morbidities, including BPD and pneumothorax .Studies have shown that birth weight and male gender are risk factors for CPAP failure . To mitigate CPAP failure, and in parallel with technological advances in the field of neonatal ventilators, different modes of non-invasive ventilation (NIV) have been introduced, with nasal intermittent positive-pressure ventilation (NIPPV) being the most frequently used alternative. Multiple studies have studied CPAP failure but very few studies on NIPPV failure.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • • Gestational age (GA) between 26 and less than 37 weeks weeks.
  • GA will be determined by dates or a dating ultrasound.
  • • Clinical and radiological Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting and chest Xray suggestive of RDS.

排除标准

  • 1.Any baby intubated for resuscitation or for other reasons.
  • Major congenital malformations or known complex congenital heart disease.

结局指标

主要结局

To study incidence, risk factors of noninvasive intermittent positive pressure ventilation (NIPPV) failure, defined as the need for intubation within 72 hours of life

时间窗: First 72 hours of life

次要结局

  • 1. Days of hospitalization,(2. Days on NIV,)

研究者

发起方
Dr Sonali Amol Avale
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Amol Avale

Government Medical college , Sambhaji Nagar

研究点 (1)

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