Effectiveness of High Velocity Nasal Insufflation (HVNI) in Infants <32 Weeks Gestational Age(GA) or Birth Weight <1500 Grams With Moderate Respiratory Distress in Dr.Cipto Mangunkusumo Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Effectiveness of HVNI to prevent intubation within 72 hours
研究概览
简要总结
Neonatal respiratory distress is a common problem in preterm infants. The application of CPAP is widely used in neonatal units as a primary mode of respiratory support for respiratory distress. However, discomfort, nasal injuries, and fixation difficulties have been reported as obstacles when applying CPAP. High velocity nasal insufflation (HVNI) may serve as an alternative to CPAP. Trials are needed to evaluate the effectiveness of HVNI in reducing the incidence of respiratory distress. The aim of this study is to compare the clinical effectiveness and safety of HVNI as an alternative therapy to CPAP in premature infants with moderate respiratory distress. This study is a prospective, non-inferiority, randomized, unblinded controlled trial to compare the efficacy of HVNI and CPAP. The subjects were randomly allocated to receive either HVNI or CPAP according to the study protocol. They were randomly assigned using blocks of four. The completion of HVNI therapy was determined by therapeutic failure within 72 hours following enrollment, indicated by the need for intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants born in Cipto Mangunkusumo Hospital with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams.
- •Infants with moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.
- •Parents are willing to participate in the study.
排除标准
- •Infants with severe respiratory distress (Downe score ≥ 6) requiring invasive treatment in the form of mechanical ventilation, or apnea indicated by surfactant administration via endotracheal tube.
- •Infants with contraindications to the use of non-invasive ventilation such as esophageal atresia, diaphragmatic hernia, air leak syndrome, and other conditions.
- •Infants with respiratory distress due to non-pulmonary abnormalities.
- •Infants with congenital metabolic disorders.
- •Infants with congenital abnormalities that exacerbate respiratory distress.
结局指标
主要结局
Effectiveness of HVNI to prevent intubation within 72 hours
时间窗: Intubation rates within 72 hours
The primary outcome was treatment failure/success within 72 hours of treatment between HVNI and CPAP
次要结局
- Length of stay(30 days)
研究者
Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K)
Principal Investigator of Perinatology Division
Indonesia University