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Completed

NCT Number: NCT07326761

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

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.

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Key information

Age range

1 hour–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510317, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Particle number of neonatal blood sample

    Time frame: parenteral nutrition support for over 14 days,parenteral nutrition support for 3-7 days,The first day after birth

    The number of microplastics granules in newborn blood was detected.

Secondary outcomes

  1. Education

    Time frame: Day 1

    questionnaire

  2. Occupation

    Time frame: Day 1

    questionnaire

  3. Annual income per capita (CNY)

    Time frame: Day 1

    questionnaire

  4. Parity

    Time frame: Day 1

    questionnaire

  5. Mode of conception

    Time frame: Day 1

    questionnaire

  6. Birth outcome

    Time frame: Day 1

    questionnaire

  7. Sex of newborns

    Time frame: Day 1

    physiological parameter

  8. Mode of delivery

    Time frame: Day 1

    physiological parameter

  9. Newborn weight (kg)

    Time frame: Day 1

    physiological parameter

  10. Length of intravenous nutrition

    Time frame: Day 1

    physiological parameter

Sponsors and collaborators

Lead sponsor

Huiyi Li

Other

Registry information

Acronym: Microplastics

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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