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临床试验/NCT06620107
NCT06620107已完成不适用

Noninvasive High Frequency Oscillation Ventilation (NHFOV) in Comparison to Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) As Post-extubation Support in Preterm Neonates

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
reintubation and the duration of respiratory support

研究概览

简要总结

comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.

详细描述

The global definition of preterm infant by the World Health Organization is any infant born before 37 weeks of gestation. Annually, an estimated 15 million (11.1%) preterm infants are born worldwide. Preterm birth is further classified as extremely preterm (<28 weeks), very preterm (28 to <32 weeks), and moderate (32 to <34 weeks) to late preterm (34 to <37 weeks).

Prematurity has been associated with several risk factors, such as history of previous preterm birth, pregnancy induced hypertension, premature rupture of fetal membranes, multiple pregnancy, bleeding during pregnancy, history of abortion, fetal malformation, inadequate antenatal care, polyhydramnios and previous caesarean section.

Preterm neonates are at greater risk of a range of short-term and long-term morbidities. Respiratory distress syndrome (RDS) is one of the most common causes of morbidity and mortality in preterm infants. RDS is characterized by a lack of lung surfactant. Insufficient surfactant production or secretion results in higher alveolar surface tension, leading to atelectasis and impaired gas exchange. Respiratory distress typically manifests in newborns as tachypnea, intercostal retractions, nasal flaring, grunting, and cyanosis.

Invasive mechanical ventilation (IMV) increases survival in preterm infants with severe RDS. However, prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including, ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia, and nosocomial pneumonia, and also increases the risk of a poor neurodevelopmental outcome. Therefore, when caring for premature infants, clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support (NRS).

There are many strategies and criteria for weaning, including evaluation of ventilatory parameters, clinical/biochemical criteria, and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
  • When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
  • Criteria for extubation:
  • Blood gas analysis: PH > 7.25 and PaCO2 ≤ 60 mmHg.
  • Airway pressure (Paw) of 7 to 8 cmH2O.
  • Required fraction of inspired oxygen (FiO2) ≤ 30%.
  • Sufficient spontaneous breathing by clinical evaluation.

排除标准

  • Full term neonates.
  • Preterm neonates who will not require intubation.
  • Preterm neonates with one of the following criteria:
  • birth weight > 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
  • Cases that require reintubation after more than 72 hours of extubation.

结局指标

主要结局

reintubation and the duration of respiratory support

时间窗: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..

* The number of cases that required re-intubation and the time of failure of extubation in hours. * Duration of different types of respiratory support since birth till discharge from NICU.

次要结局

  • complications(from the date of birth till the date of discharge from NICU or death (assessed up to 3 months).)

研究者

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

Wafaa Mahmoud Hassan Abouseada

pediatric demonstrator at faculty of medicine- kafrelsheikh university

Kafrelsheikh University

研究点 (1)

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NHFOV Vs NIPPV Post-extubation in Preterm Neonates | 临床试验