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NCT Number: NCT07646925

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

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.

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Key information

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Aluminum exposure level

    Time frame: 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 outcomes

  1. Complications in preterm infants

    Time frame: From birth to 4 weeks postnatal age

    Incidences of prematurity-related complications such as feeding intolerance, necrotizing enterocolitis, bronchopulmonary dysplasia

Sponsors and collaborators

Lead sponsor

Han Tongyan

Other

Registry information

Official study title

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

Acronym: PN-Al POCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.