Preliminary Study on Microplastics Deposition in Ventilator Circuit and the Risk of Bronchopulmonary Dysplasia in Premature Infants

NCT07848646 | Not Yet Recruiting DMC

• 1 other identifier: 2026-KY-KZ-146-02
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the premature infants with gestational age less than 30 weeks were taken as the object, and the deposition characteristics of microplastics in ventilator circuit and its correlation with the risk of bronchopulmonary dysplasia were systematically discussed through prospective observation design. The research is divided into two parts: firstly, the release and deposition of microplastics in the ventilator circuit (water storage tank and simulated lung) are detected; Secondly, the changes of microplastics load in airway secretions of children with bronchopulmonary dysplasia on the 0-7th day, 14th day and 28th day were dynamically monitored, and samples of bottle milk and newborn blood were collected simultaneously to evaluate the exposure level of multi-channel microplastics. Microplastics was qualitatively and quantitatively analyzed by confocal micro-Raman spectroscopy, and the dose-response relationship between microplastics load and bronchopulmonary dysplasia was analyzed in combination with clinical data, so as to provide scientific basis for risk prevention and control of iatrogenic microplastics exposure in neonatal intensive care unit. In this study, the blood sample only used the remaining venous blood collected by routine clinical diagnosis and treatment (such as blood routine and blood gas analysis) on the 7th, 14th and 28th day (2 days) after the newborn was admitted to the hospital, and the dosage was 0.5-1 mL, which was placed in a glass anticoagulant tube. Each child is collected at most once. If there is no clinical blood collection at this time point, no additional puncture blood collection will be carried out to ensure that the operating burden and risk of children will not be increased.

Conditions

Bronchopulmonary Dysplasia

Keywords

Premature baby; Microplastics; Ventilator circuit; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• Microplastics deposition of airway secretions.

  Measure the average particle size, quantity and type of microplastics.

  up to 4 weeks

Secondary Outcomes (1)

• Incidence of bronchopulmonary dysplasia

  1 month

Study Arms (2)

BPD group

Non-BPD group

Eligibility Criteria

• Age: 1 Minute - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with invasive mechanical ventilation

Sponsors & Collaborators

• Huiyi Li: lead

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of the nurse, the Second People's Hospital of Guangdong Province

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09