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

23 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 minut till 1 månad (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Neonates with invasive mechanical ventilation

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
BPD group
Non-BPD group

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Microplastics deposition of airway secretions.
Tidsram: up to 4 weeks

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

up to 4 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of bronchopulmonary dysplasia
Tidsram: 1 month

incidence rate

1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 oktober 2027

Avslutad studie (Beräknad)

30 oktober 2027

Studieregistreringsdatum

Först inskickad

14 september 2026

Först inskickad som uppfyllde QC-kriterierna

23 september 2026

Första postat (Faktisk)

30 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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