Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Length of NICU stay (days)
研究概览
简要总结
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support.
The primary outcome measure is length of NICU stay.
详细描述
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.
The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
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)
盲法说明
Clinical care teams cannot be blinded due to the nature of the intervention. Outcome assessors and statisticians analyzing study outcomes will remain blinded to group assignment. Therefore it will be single masked.
入排标准
- 年龄范围
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants admitted to the Tufts Medical Center NICU
- •Requiring invasive or non-invasive respiratory support
- •Requiring surfactant therapy
- •Parental or guardian informed consent obtained
排除标准
- •Major congenital anomalies
- •Known chromosomal abnormalities
- •Congenital diaphragmatic hernia
- •Decision for comfort care
- •Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
研究组 & 干预措施
Intervention - Lung ultrasound guided respiratory management
Participants randomized to this group will under lung ultrasound assessments at predefined clinical time points. Lung ultrasound scores will guide:
- Surfactant administration in the early neonatal period
- Weaning from non-invasive respiratory suppport
- Transition to room air
Decisions will follow predefined lung ultrasound score thresholds using a validating scoring system. Ultrasounds to be performed by trained neonatal providers using standardized techniques. Attending neonatologists may override protocol recommendations if clinically necessary, with documentation
干预措施: Lung ultrasound-guided respiratory management (Procedure)
Control - Standard Clinical Care
Participants randomized to this group will receive respiratory management based on standard NICU clinical criteria including oxygen requirement, work of breathing, blood gas measurements, and radiographic findings. Lung ultrasound may be performed if clinically indicated, but will not be used for protocolized decision making.
结局指标
主要结局
Length of NICU stay (days)
时间窗: From date of NICU admission to date of hospital discharge up to one year
次要结局
- Duration of any respiratory support(From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year)
- Duration of non-invasive respiratory support(From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.)
- Time to successful weaning to room air(From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.)
- Weaning failure(From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours)
- Need for reintubation(From date of extubation, to date of reintubation, up to 72 hours.)
- Number of surfactant doses administered(Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.)
- Mortality prior to discharge(From date of birth until the date of death from any cause, assessed up to one year.)