Preliminary Study on Microplastics Deposition in Ventilator Circuit and the Risk of Bronchopulmonary Dysplasia in Premature Infants (Microplastics)
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.
調査の概要
状態
状態
条件
条件
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Neonates with invasive mechanical ventilation
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:CASE_CONTROL
- 時間の展望:PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
|---|
|
BPD group
|
|
Non-BPD group
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Microplastics deposition of airway secretions.
時間枠:up to 4 weeks
|
Measure the average particle size, quantity and type of microplastics. |
up to 4 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of bronchopulmonary dysplasia
時間枠:1 month
|
incidence rate |
1 month
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2026-KY-KZ-146-02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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