Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral Nutrition Formulations for Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Trace Aluminum Ions in Parenteral Nutrition. Basic parameters: 0 Days — 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral
Overview
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.
Primary outcome measures
- Aluminum exposure level [Time frame: From birth to 4 weeks postnatal age.]
Secondary outcome measures (1)
- Complications in preterm infants [Time frame: From birth to 4 weeks postnatal age]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07646925 · M20260023