Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral Nutrition Formulations for Preterm Infants

NCT07646925 | Not Yet Recruiting

• 1 other identifier: M20260023
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Trace Aluminum Ions in Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications in preterm infants

  From birth to 4 weeks postnatal age

Study Arms (1)

High Al Exposure / Low Al Exposure

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Han Tongyan: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06