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

NCT07326761 | Completed DMC

• 1 other identifier: 2025-KY-KZ-164-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Microplastics Exposure

Keywords

Microplastics; Parenteral Nutrition; newborns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Education

  Day 1

• Occupation

  Day 1

• Annual income per capita (CNY)

  Day 1

• Parity

  Day 1

• Mode of conception

  Day 1

Study Arms (3)

Long-term exposure group

ACTIVE COMPARATOR

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

Short-term exposure group

PLACEBO COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

No Intervention: Observational Cohort BEHAVIORAL

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

Long-term exposure group; Short-term exposure group

Eligibility Criteria

• Age: 1 Hour - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huiyi Li: lead

Study Sites (1)

The Second People's Hospital of Guangdong Province affiliated to Jinan University

Guangzhou, Guangdong, 510317, China

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of the nurse, the Second People's Hospital of Guangdong Province

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)