Heated Humidified High-Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure as Primary Respiratory Support in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
研究概览
简要总结
This single-center randomized controlled trial compared heated humidified high-flow nasal cannula (HHHFNC) with nasal continuous positive airway pressure (nCPAP) as primary noninvasive respiratory support in preterm infants (gestational age 28-34 weeks; birth weight 1000-2000 g) with moderate respiratory distress syndrome. The primary outcome was treatment failure requiring invasive mechanical ventilation within the first 7 days.
详细描述
Eighty-six infants were randomized 1:1 to HHHFNC (n=43) or nCPAP (n=43). Both arms followed identical surfactant, escalation, and weaning protocols. Outcomes included treatment failure, nasal trauma, sepsis, feeding intolerance, and time to full enteral feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants admitted to the NICU who fulfilled all of the following were eligible:
- •Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g
- •Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS)
- •Silverman-Anderson score (SAS) 4 < SAS < 7
- •Eligibility for noninvasive ventilatory support
排除标准
- •Parental refusal of consent
- •Outborn infants transferred from other centers
- •Infants who required immediate intubation in the delivery room
- •Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects
- •Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip)
- •Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3)
- •Infants who died unexpectedly shortly after admission without respiratory evaluation
结局指标
主要结局
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
时间窗: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
Treatment failure defined as the need for invasive mechanical ventilation per pre-specified criteria (FiO2 \>=0.60 to maintain SpO2 91-95%; pH \<7.20 with PaCO2 \>60 mmHg; recurrent or caffeine-refractory apnea; markedly increased work of breathing; or clinical deterioration determined by the attending neonatologist), assessed at 72 hours, Day 5, and Day 7 of life.
次要结局
- Number of Participants With Nasal Trauma(During noninvasive respiratory support (first 7 days of life))
- Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis(From 72 hours of life through hospital discharge, an average of 24 days)
- Number of Participants With Bronchopulmonary Dysplasia (BPD)(At 36 weeks postmenstrual age)