NCT07100652尚未招募不适用
Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT
Jiulongpo No.1 People's Hospital1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2026年1月1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
- 384
- 试验地点
- 1
- 主要终点
- Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth
研究概览
简要总结
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ >0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.
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
- — 至 3 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Gestational Age: 26 weeks +0 day to 31 weeks+6days at birth (inclusive). (2) Clinical Diagnosis of NRDS: Symptoms: Tachypnea, grunting, and/or progressive respiratory distress. Imaging Findings: Chest X-ray showing at least one of: Ground-glass opacity, Air bronchograms, Diffuse "white lung" pattern, Lung Ultrasound (recommended).
- •(3) Admission to NICU within 3 hours of birth. Requirement for non-invasive nasal intermittent positive pressure ventilation (NIPPV) at enrollment.
- •(4) Signed informed consent obtained from parent(s) or legal guardian(s).
排除标准
- •Invasive mechanical ventilation during delivery or transport to NICU.
- •Structural upper airway abnormalities precluding non-invasive ventilation.
- •Confirmed diagnosis of major congenital malformations
- •Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
- •Initiation of non-invasive ventilation >3 hours post-birth.
- •Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.
- •Parental/guardian refusal to Sign informed consent or Authorize surfactant administration
- •Incomplete clinical records or missing key outcome variables
结局指标
主要结局
Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth
时间窗: 72 hours after birth
次要结局
- The requirement for repeated pulmonary surfactant administration, including the total number of doses utilized(7 days after birth)
- BPD, defined according to the NICHD definition(3 months after birth)
- IVH > 2nd grade(3 mionths after birth)
- total hospitalization cost(6 months after birth)
- retinopathy of prematurity (ROP) > 2nd stage(3 months after birth)
- weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first.(3 months after birth)
- Duration of non-invasive respiratory support(3 months after birth)
- airleaks occurred after the extubation(3 months after birth)
- necrotizing enterocolitis (NEC) ≥ 2nd stage(3 months after birth)
- nasal skin injury(3 months after birth)
- ventilator-free days(3 months after birth)
- hemodynamically significant patent ductus arteriosus (PDA)(3 months after birth)
- in-hospital mortality(6 months after birth)
研究者
Xingwang Zhu
Jiangxi Maternal and Child Health Hospital, Jiangxi, 337000, China
Jiulongpo No.1 People's Hospital
研究点 (1)
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