Lung Ultrasound-Guided Positioning Strategy for the Prevention of Ventilator-Associated Pneumonia in Neonates (LUS-POSforVAP)

Huiyi Li

Status: Completed

Conditions: Pneumonia

Treatments: Behavioral: standard positioning management; Behavioral: Lung Ultrasound Guided Localization

Study type: Interventional

Funder types: Other

Identifiers

NCT07254507

2023-KY-KZ-266-02

2024A03J0771 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 1 hour to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible participants included term neonates (gestational age 37-42 weeks) who required invasive mechanical ventilation for more than 48 hours.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Standard positioning management

Placebo Comparator group

Description:

NICU routine nursing

Treatment:

Behavioral: standard positioning management

LUS-Guided Group (Lung Ultrasound-Guided Positioning)

Experimental group

Description:

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.

Treatment:

Behavioral: Lung Ultrasound Guided Localization