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Microplastic Exposure in Neonates Receiving Parenteral Nutrition: A Prospective Cohort Study in the NICU

Microplastic Exposure in Neonates Receiving Parenteral Nutrition: A Prospective Cohort Study in the NICU

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07326761
Acronym
Microplastics
Enrollment
12
Registered
2026-01-08
Start date
2025-01-01
Completion date
2025-11-01
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microplastics Exposure

Keywords

Microplastics, Parenteral Nutrition, newborns

Brief summary

The purpose of this study is to explore a potential exposure risk in the neonatal intensive care unit, namely, the iatrogenic microplastic exposure that critically ill newborns may face when receiving life-saving parenteral nutrition (intravenous nutrition delivered through a plastic infusion system). Therefore, the investigators designed a prospective study. By comparing three groups of newborns-those requiring long-term intravenous nutrition, short-term intravenous nutrition, and no intravenous nutrition-and collecting blood samples with strictly contamination-proof non-plastic instruments, the investigators used high-precision Raman spectroscopy for detection. For the first time, they attempted to systematically and quantitatively analyze the microplastic load in neonatal blood and its relationship with the duration of intravenous nutrition. The aim of this study is to provide novel scientific evidence for evaluating microplastic exposure in the neonatal medical environment, with the ultimate goal of establishing a basis for developing safer clinical practices and medical material standards in the future, thereby better protecting the long-term health of vulnerable newborns.

Detailed description

BACKGROUND: As a new environmental pollutant, microplastics has been found in many tissues of human body. Newborns, especially those who need intensive care and parenteral nutrition, may face a unique and persistent risk of microplastics exposure through plastic medical equipment, but their internal load is not clear. Objective: The purpose of this study is to systematically evaluate the microplastics exposure of newborns in neonatal intensive care unit (NICU) during hospitalization through a prospective observation cohort, focusing on the potential relationship between the duration of parenteral nutrition and microplastics load. Methods: Twelve newborns were recruited in 2025, and were divided into long-term exposure group, short-term exposure group and unexposed control group according to the support time of parenteral nutrition. In this study, blood samples of newborns were collected under strict pollution control, and microplastics in the samples was qualitatively and quantitatively analyzed by confocal micro-Raman spectroscopy.

Interventions

BEHAVIORALNo Intervention: Observational Cohort

These infants received neither intravenous nutritional support nor planned fluid therapy, serving as baseline microplastic levels in the absence of iatrogenic exposure.

Sponsors

Huiyi Li
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Months
Healthy volunteers
No

Inclusion criteria

* Newborns hospitalized in neonatal intensive care unit of Guangdong Second People's Hospital in 2025. * The gestational age of birth is ≥ 28 weeks. * Intravenous nutrition time is 1-56 days. * The mother has no serious basic diseases (such as heart disease, chronic kidney disease, mental illness, hypertension, diabetes, etc.).

Exclusion criteria

* There are serious congenital malformations or chromosomal abnormalities. Combined with other serious diseases that may affect the metabolism or distribution of microplastics (such as congenital metabolic abnormality, liver or renal insufficiency). * Parents or legal guardians withdraw informed consent. * Death or automatic discharge within 72 hours after birth.

Design outcomes

Primary

MeasureTime frameDescription
Particle number of neonatal blood sampleparenteral nutrition support for over 14 days,parenteral nutrition support for 3-7 days,The first day after birthThe number of microplastics granules in newborn blood was detected.

Secondary

MeasureTime frameDescription
OccupationDay 1questionnaire
Annual income per capita (CNY)Day 1questionnaire
ParityDay 1questionnaire
Mode of conceptionDay 1questionnaire
EducationDay 1questionnaire
Sex of newbornsDay 1physiological parameter
Mode of deliveryDay 1physiological parameter
Newborn weight (kg)Day 1physiological parameter
Length of intravenous nutritionDay 1physiological parameter
Birth outcomeDay 1questionnaire

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026