Microplastics ExposureMicroplasticsNCT07326761
Microplastic Exposure in Neonates Receiving Parenteral Nutrition: A Prospective Cohort Study in the NICU
A study of Microplastics Exposure, run by Huiyi Li at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 hour to 2 months
- Conditions the study is for
- Microplastics Exposure
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second People's Hospital of Guangdong Province affiliated to Jinan University
Guangzhou, Guangdong, 510317
About this study
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.
Read the 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.
- Conditions
- Microplastics Exposure
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Microplastics, Parenteral Nutrition, newborns
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortBehavioural
These infants received neither intravenous nutritional support nor planned fluid therapy, serving as baseline microplastic levels in the absence of iatrogenic exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Particle number of neonatal blood sample
The number of microplastics granules in newborn blood was detected.
Measured: parenteral nutrition support for over 14 days，parenteral nutrition support for 3-7 days，The first day after birth
Secondary outcomes (10)
Education
questionnaire
Measured: Day 1
Occupation
questionnaire
Measured: Day 1
Annual income per capita (CNY)
questionnaire
Measured: Day 1
Parity
questionnaire
Measured: Day 1
Mode of conception
questionnaire
Measured: Day 1
Birth outcome
questionnaire
Measured: Day 1
Sex of newborns
physiological parameter
Measured: Day 1
Mode of delivery
physiological parameter
Measured: Day 1
Newborn weight (kg)
physiological parameter
Measured: Day 1
Length of intravenous nutrition
physiological parameter
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microplastics ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huiyi Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huiyi Li, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326761
- Sponsor's protocol ID
- 2025-KY-KZ-164-02
- Acronym
- Microplastics
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xu D, Liang Z, Yang Q, Li L, Li H, You C, Meng Q, Zhou W. Microplastics in neonates: an overlooked cost of parenteral nutrition. Front Public Health. 2026 Apr 7;14:1767555. doi: 10.3389/fpubh.2026.1767555. eCollection 2026.
PubMed 42022813
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microplastic Exposure in Neonates Receiving Parenteral Nutrition: A Prospective Cohort Study in the NICU
- ClinicalTrials.gov ID
- NCT07326761
- Acronym / sponsor ID
- Microplastics / 2025-KY-KZ-164-02
- Conditions
- Microplastics Exposure
- Keywords
- Microplastics, Parenteral Nutrition, newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Huiyi LiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-term exposure group | Active comparator | Behavioral: No Intervention: Observational CohortPremature 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 |
| Short-term exposure group | Placebo comparator | Behavioral: No Intervention: Observational CohortPremature 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. |
| 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. |
Who may qualify
- Ages
- 1 hour to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThese infants received neither intravenous nutritional support nor planned fluid therapy, serving as baseline microplastic levels in the absence of iatrogenic exposure. | Behavioural | Long-term exposure group, Short-term exposure group |
Primary outcome
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.
10 secondary outcomes
Education
Time frame: Day 1
Occupation
Time frame: Day 1
Annual income per capita (CNY)
Time frame: Day 1
Parity
Time frame: Day 1
Mode of conception
Time frame: Day 1
Birth outcome
Time frame: Day 1
Sex of newborns
Time frame: Day 1
Mode of delivery
Time frame: Day 1
Newborn weight (kg)
Time frame: Day 1
Length of intravenous nutrition
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 42022813Xu D, Liang Z, Yang Q, Li L, Li H, You C, Meng Q, Zhou W. Microplastics in neonates: an overlooked cost of parenteral nutrition. Front Public Health. 2026 Apr 7;14:1767555. doi: 10.3389/fpubh.2026.1767555. eCollection 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Microplastics Exposure, run by Huiyi Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.