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

NCT07254507 | Completed DMC

• 2 other identifiers: 2023-KY-KZ-266-022024A03J0771
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Keywords

Pulmonary ultrasound; Body position management; Neonatal ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator-associated pneumonia in neonates

  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.

  From randomization until VAP diagnosis, successful extubation, or death, whichever occurs first, assessed up to 100 days.

Secondary Outcomes (7)

• 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.

Study Arms (2)

Standard positioning management

PLACEBO COMPARATOR

NICU routine nursing

Behavioral: standard positioning management

LUS-Guided Group (Lung Ultrasound-Guided Positioning)

EXPERIMENTAL

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.

Behavioral: Lung Ultrasound Guided Localization

Interventions

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.

Standard positioning management

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.

LUS-Guided Group (Lung Ultrasound-Guided Positioning)

Eligibility Criteria

• Age: 1 Hour - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Huiyi Li: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510317, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse, Deputy Director of Pediatrics, the Second People's Hospital of Guangdong Province affiliated to Jinan University.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be provided within 6 months after the publication of the main results of this study, and the data will be shared for at least 5 years.
• Access Criteria: To provide researchers who provide research proposals with rigorous methodology and clear scientific objectives for achieving the research objectives in the approved proposals. It usually includes meta-analysis of individual participant data, verification of results, or exploration of new scientific hypotheses that conform to the original research ethical framework.The proposal should be submitted to: liangzhenyu0823@163.com (please note: please replace this with the official contact email you wish to use). To gain access, the applicant needs to sign a data use agreement. The research steering committee of this study will review the scientific value and methodological rigor of the proposal.

Locations

CN (1)