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Completed

NCT Number: NCT07254507

Lung Ultrasound-Guided Positioning Strategy for the Prevention of Ventilator-Associated Pneumonia in Neonates

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 hour–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second People's Hospital of Guangdong Province affiliated to Jinan University

Guangzhou, Guangdong, 510317, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard positioning management

Behavioral

Infants in the control group had their positions adjusted every two hours, alternating between supine, left lateral, right lateral, and prone positions.The head of the bed should be elevated 15°-30° with the body in a slightly flexed position-hips aligned along the midline, shoulders slightly forward, head centered, and arms free to move. Position adjustments should only be made when vital signs are stable and resuscitation is delayed, or when adjusting the ventilator, administering IV fluids, or managing deep sleep. If heart rate fluctuates more than 20 beats per minute or SpO₂ drops below 90% (excluding airway obstruction), the interval between position adjustments should be extended to 3-4 hours. This group did not undergo ultrasound evaluation.

Lung Ultrasound Guided Localization

Behavioral

In addition to routine care, two LUS assessments are conducted at fixed times daily (08:00 and 18:00) to guide individualized position adjustments by monitoring regional ventilation.①If unilateral atelectasis or pulmonary edema is detected, the patient should first be maintained in dependent lateral position for approximately 1 hour, then transition to the contralateral or prone position for 3 hours.②For lesions previously managed by the department, the prone position duration is reduced to 1 hour, while supine or lateral positions are extended to 3 hours. ③For posterior lesions, the supine or lateral position should be limited to 1 hour, while the prone position should be extended to 3 hours.④Resume the standard two-hour shift system once the symptoms or edema have subsided.If SpO₂ remains persistently below 90% (excluding operational or feeding disturbances), the respiratory rate increases by more than 20 breaths per minute from baseline, an additional LUS evaluation is required.

Primary outcomes

  1. Incidence of ventilator-associated pneumonia in neonates

    Time frame: 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.

Secondary outcomes

  1. feeding intolerance in newborns

    Time frame: 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.

    Incidence of feeding intolerance at any level (mild+severe)

  2. Pulmonary hemorrhage

    Time frame: 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

    Incidence of any grade of pulmonary hemorrhage

  3. Pneumothorax

    Time frame: 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

    Incidence of pneumothorax

  4. new intracranial hemorrhage

    Time frame: 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.

    The incidence of any new intracranial hemorrhage (including symptomatic and asymptomatic)

  5. Mortality

    Time frame: 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.

    Mortality during hospitalization

  6. Duration of invasive mechanical ventilation

    Time frame: 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.

    Duration of ventilator use: from start to successful extubation or death.

  7. NICU hospitalization duration

    Time frame: 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.

    Time from admission to discharge for hospitalization

Sponsors and collaborators

Lead sponsor

Huiyi Li

Other

Registry information

Official study title

Evaluation of Lung Ultrasound-Guided Posture Management for Improving Outcomes in Neonatal Ventilator-Associated Pneumonia

Acronym: LUS-POSforVAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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