Trace Aluminum Ions in Parenteral Nutrition
Conditions
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.
Interventions
None listed
Sponsors
Han Tongyan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aluminum exposure level | From birth to 4 weeks postnatal age. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications in preterm infants | From birth to 4 weeks postnatal age | Incidences of prematurity-related complications such as feeding intolerance, necrotizing enterocolitis, bronchopulmonary dysplasia |
Outcome results
None listed