Evaluation of Lung Ultrasound-Guided Posture Management for Improving Outcomes in Neonatal Ventilator-Associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of ventilator-associated pneumonia in neonates
研究概览
简要总结
This study aims to determine if using lung ultrasound to guide personalized positioning for ventilated newborns is more effective than standard repositioning at preventing ventilator-associated pneumonia.
详细描述
This research study is testing a new strategy to help prevent Ventilator-Associated Pneumonia(VAP) in newborns who need a breathing machine (mechanical ventilator). VAP is a serious lung infection that can sometimes occur in the hospital.We are using abedside Lung Ultrasound (LUS). This is a safe, painless, and radiation-free imaging tool. It allows doctors to see how well different parts of a baby's lungs are inflated in real-time, much like a "window" into the lungs.Based on the lung ultrasound pictures,our healthcare team will create a personalized positioning plan for the baby (for example, placing them more on their side or on their tummy). The goal is to use gravity to help open up the lungs and drain any fluid, which may lower the risk of infection. We will compare this new method to the standard practice of turning babies every two hours.We believe this personalized,evidence-based care strategy could be more effective in preventing pneumonia. It may potentially help babies get off the breathing machine sooner and reduce their time in the neonatal intensive care unit (NICU).Lung ultrasound is a well-established and safe bedside procedure.This study has been carefully reviewed and approved by the hospital's Ethics Committee. All procedures will be performed by trained doctors and staff, with the baby's safety and comfort as our top priority.
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 (Participant)
入排标准
- 年龄范围
- 1 Hour 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants included term neonates (gestational age 37-42 weeks) who required invasive mechanical ventilation for more than 48 hours.
排除标准
- •Exclusion criteria included ①preterm neonates; ② Neonates with early sepsis or previous pneumonia;③ Not suitable for patients with enteral nutrition;④ Newborns requiring mechanical ventilation due to surgery;⑤ There are many infants with congenital abnormalities or suspected chromosomal abnormalities.
研究组 & 干预措施
Standard positioning management
NICU routine nursing
干预措施: standard positioning management (Behavioral)
LUS-Guided Group (Lung Ultrasound-Guided Positioning)
In addition to standard care, LUS assessments were conducted twice daily at fixed time points (08:00 and 18:00) to evaluate regional aeration and guide individualized postural adjustments.
干预措施: Lung Ultrasound Guided Localization (Behavioral)
结局指标
主要结局
Incidence of ventilator-associated pneumonia in neonates
时间窗: From randomization until VAP diagnosis, successful extubation, or death, whichever occurs first, assessed up to 100 days.
Pneumonia that occurs 48 hours after mechanical ventilation (MV) and 48 hours after extubation is an important type of Hospital-acquired pneumonia (HAP), in which pneumonia that occurs within MV≤4 days is early-onset VAP, and pneumonia that occurs within MV ≥5 days is late-onset VAP.
次要结局
- feeding intolerance in newborns(From the beginning of enteral feeding to the successful establishment of full enteral feeding, discharge or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.)
- Pulmonary hemorrhage(From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 24 hours after extubation, and the longest evaluation period is expected to be 100 days)
- Pneumothorax(From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 48 hours after extubation, and the longest evaluation period is expected to be 100 days)
- new intracranial hemorrhage(From the day of random grouping to the end of discharge or study period, whichever comes first. Routine monitoring will last until the seventh day after birth, and the longest evaluation period is expected to be 120 days.)
- Mortality(From the day of random grouping to the end of discharge or study period, whichever comes first. The longest evaluation period is expected to be 120 days.)
- Duration of invasive mechanical ventilation(Time is counted from invasive ventilation to successful extubation or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.)
- NICU hospitalization duration(Time is counted from admission to transfer out of NICU or discharge. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 120 days.)
研究者
Huiyi Li
Nurse, Deputy Director of Pediatrics, the Second People's Hospital of Guangdong Province affiliated to Jinan University.
Guangdong Second Provincial General Hospital