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

September 23, 2026 updated by: Huiyi Li

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.

Study Overview

Status

Not yet recruiting

Conditions

Bronchopulmonary Dysplasia

Detailed Description

Objective To investigate the relationship between microplastics deposition in ventilator circuit and bronchopulmonary dysplasia (BPD) in premature infants, and to evaluate the risk of iatrogenic microplastics exposure in NICU.

Methods A prospective observational cohort study was conducted. Premature infants with gestational age less than 30 weeks who needed mechanical ventilation were divided into groups according to whether BPD occurred or not. Samples of condensate water, simulated lung lavage fluid, airway secretions, blood and milk were collected, and microplastics characteristics were detected by acid digestion, vacuum filtration and confocal micro Raman spectrometer. Clinical data were collected and analyzed by multivariate statistics.

Hypothesis: It is expected that microplastics such as polyethylene and polypropylene can be detected in the ventilator circuit. Microplastics load of airway secretion in BPD group increased significantly, which was positively correlated with ventilation duration and showed an increasing trend with the course of disease. Inhalation is the main exposure route, and airway microplastics load may be an independent risk factor for BPD.

This study provides a basis for the safety assessment and clinical prevention and control of medical equipment and materials in NICU.

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates with invasive mechanical ventilation

Description

Inclusion criteria：Neonates with invasive mechanical ventilation Exclusion criteria：1、Children who died of genetic metabolism and congenital heart disease 2、Family members refused to carry out the experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: CASE_CONTROL
Time Perspectives: PROSPECTIVE

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
BPD group
Non-BPD group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microplastics deposition of airway secretions. Time Frame: up to 4 weeks	Measure the average particle size, quantity and type of microplastics.	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bronchopulmonary dysplasia Time Frame: 1 month	incidence rate	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huiyi Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)