Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral Nutrition Formulations for Preterm Infants (PN-Al POCT)

Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral

The research team will develop a series of multivalent nanozyme materials (MOF@Arg@His) to construct a sensing platform with dual-mode colorimetric and fluorescent responses, thereby markedly improving the sensitivity and selectivity for aluminum ion detection. By incorporating machine-learning algorithms, a signal-correction model will be established to enable highly accurate quantification of aluminum ions in complex matrices. Based on a clinical observational cohort, samples of PN raw materials, compounded admixtures, and infant biospecimens will be collected to systematically quantify aluminum exposure levels in preterm infants and to assess the associated risks of relevant complications. Integrating cutting-edge technological innovation with strong clinical applicability, this project aims to build a full-chain "formulation-exposure-outcome" evaluation framework, providing an intelligent detection tool and risk early-warning evidence base to enhance medication safety in neonates.

Study Overview

• Status: Not yet recruiting
• Conditions: Trace Aluminum Ions in Parenteral Nutrition

• Study Type: Observational
• Enrollment (Estimated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (<37 weeks' gestation) receiving parenteral nutrition (PN) for ≥5 days in the NICU of Peking University Third Hospital will be enrolled. Infants with severe inborn errors of metabolism, major congenital malformations, early death, or incomplete data will be excluded.

Description

Inclusion Criteria:

• Preterm infants receiving parenteral nutrition (PN) in the Neonatal Intensive Care Unit (NICU) of Peking University Third Hospital, with gestational age <37 weeks, PN administered for ≥5 days, complete clinical records, and written informed consent from parents/legal guardians.

Exclusion Criteria:

• Infants with severe inborn errors of metabolism, major congenital malformations, early death, or incomplete data will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
High Al Exposure / Low Al Exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aluminum exposure level	Cumulative aluminum exposure from parenteral nutrition will be calculated for each infant based on the measured aluminum concentration in each PN component and the daily administered volume or dose. Exposure will be expressed as μg/kg/day and cumulative μg/kg over the first 4 weeks of postnatal life. Aluminum concentrations will be measured using inductively coupled plasma mass spectrometry, or the actual validated assay used in the study.	From birth to 4 weeks postnatal age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications in preterm infants	Incidences of prematurity-related complications such as feeding intolerance, necrotizing enterocolitis, bronchopulmonary dysplasia	From birth to 4 weeks postnatal age

Collaborators and Investigators

• Sponsor: Han Tongyan

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: M20260023

Drug and device information, study documents

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