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

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.

Study Overview

• Status: Completed
• Conditions: Microplastics Exposure
• Intervention / Treatment: Behavioral: No Intervention: Observational Cohort

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510317
      • The Second People's Hospital of Guangdong Province affiliated to Jinan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Long-term exposure group; Premature infants requiring continuous parenteral nutrition support for over 14 days due to severe feeding difficulties, necrotizing enterocolitis (NEC), short bowel syndrome, or other serious intestinal diseases	Behavioral: No 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.
Placebo Comparator: Short-term exposure group; Premature infants receiving parenteral nutrition support for 3-7 days due to early adaptation issues (e.g., respiratory distress, temporary feeding intolerance) and having successfully transitioned to total parenteral nutrition for at least 48 hours prior to blood sample collection. This group represents common short-term iatrogenic exposure in NICU settings.	Behavioral: No 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.
No Intervention: Control group; The study included healthy full-term newborns born at 37 weeks or later gestational age. These infants received neither intravenous nutritional support nor planned fluid therapy, serving as baseline microplastic levels in the absence of iatrogenic exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Particle number of neonatal blood sample	The number of microplastics granules in newborn blood was detected.	parenteral nutrition support for over 14 days，parenteral nutrition support for 3-7 days，The first day after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Education	questionnaire	Day 1
Occupation	questionnaire	Day 1
Annual income per capita (CNY)	questionnaire	Day 1
Parity	questionnaire	Day 1
Mode of conception	questionnaire	Day 1
Birth outcome	questionnaire	Day 1
Sex of newborns	physiological parameter	Day 1
Mode of delivery	physiological parameter	Day 1
Newborn weight (kg)	physiological parameter	Day 1
Length of intravenous nutrition	physiological parameter	Day 1

Collaborators and Investigators

• Sponsor: Huiyi Li

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Parenteral Nutrition; newborns; Microplastics
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperphagia
• Other Study ID Numbers: 2025-KY-KZ-164-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No