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NCT Number: NCT07414576

AI-driven Total Parenteral Nutrition Platform

This study tests whether an artificial intelligence (AI) tool can help doctors order total parenteral nutrition (TPN) for babies in the neonatal intensive care unit (NICU). Premature babies often cannot eat by mouth and need nutrition delivered through an IV. Ordering TPN is complex, time-consuming, and mistakes can happen. This study will test an AI tool that suggests TPN formulas to doctors based on each baby's lab values and health information. Doctors can accept, change, or reject the suggestions at any time. The main goal is to measure how often doctors accept the AI suggestions. The study will also track time to complete TPN orders, weight changes, days on TPN, whether lab values stay in normal ranges, provider satisfaction, and baby health outcomes including complications such as lung disease, brain bleeding, infections, and other conditions common in premature babies. Babies admitted to the NICU who need TPN may participate if their doctors agree to use the tool. Each baby will be in the study while they need TPN, typically about 14 days. The AI tool only makes suggestions and does not replace doctor decision-making. All other care remains the same as standard practice.

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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Our AI-driven TPN (TPN2.0) platform is a combination of AI and a premade set of TPN units. The AI is used to formulate and assign the optimal TPN unit to each infant, given their daily profile and lab test values. It is driven by decades of data, including our published morbidity risks, basic demographics, and routinely collected lab test values. The approach will save staff time and eliminate high errors in the current TPN ordering process.

Our pilot will be deployed as a clinical decision support tool that only makes recommendations, and doctors can always override it. As such, this minimally affects the current practice. We aim to enroll 260 neonates in this pilot study. The primary outcome is physician acceptance rate of TPN2.0 recommendations. Secondary outcomes include time to complete TPN orders, change in weight z-score, days on TPN, lab value abnormalities (values outside normal range), provider satisfaction, and a composite morbidity index comprising rates of bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity, respiratory distress syndrome, congenital heart disease, sepsis, anemia, intraventricular hemorrhage, cholestasis, jaundice, pulmonary hemorrhage, pulmonary hypertension, readmission during the study, and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any newborns or infants requiring total parenteral nutrition in a neonatal ICU that performs daily laboratory tests
  • 6-month old at the time of admission
  • Any gestational age or birthweight
  • Any race or sex

Exclusion criteria

  • Infants deem unfit for the suggested TPN due to safety concerns by physicians

Treatment and study plan

AI-driven total parenteral nutrition (TPN)

Device

An AI-driven clinical decision support (CDS) software integrated with EHR system that provides TPN composition recommendations to NICU providers. The tool uses patient lab values, basic profile (days since birth, weight, gestational age), and physician inputs to suggest TPN components. Providers can accept, modify, or decline if needed. The final prescribing authority remains with the providers. The intervention targets provider workflow efficiency while maintaining precision and equivalent patient outcomes (including labs and long-term adverse outcomes).

Primary outcomes

  1. System Acceptance Rate

    Time frame: 10 months

    Percentage of AI-generated recommendations that are accepted or modified by providers for each ingredient of TPN. Measured by retrospective comparison between AI suggestion and actual TPN order submitted.

Secondary outcomes

  1. Change in Weight Z-Score

    Time frame: 10 months

    Change in weight-for-age z-score from admission to discharge. Calculated from daily weights recorded in EMR. Target is to maintain or improve z-score trajectory in Period 2 compared to Period 1.

  2. Days on TPN

    Time frame: 10 months

    Number of days the infants have to get TPN

  3. Composite Clinical Outcome

    Time frame: 13 months

    Outcome Measure: Composite Clinical Outcome

    Description: Number and proportion of participants who experienced at least one of the following neonatal morbidities during the study period: bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), congenital heart disease (CHD), sepsis, anemia, intraventricular hemorrhage, cholestasis, jaundice, pulmonary hemorrhage, pulmonary hypertension, hospital readmission during the study period, or mortality.

    Each morbidity is assessed in the same unit -- as present or absent. Participants experiencing one or more listed morbidities are counted once in the composite outcome.

  4. Rate of Laboratory Value Abnormalities

    Time frame: 10 months

    Outcome Measure: Abnormal Serum Laboratory Values Description: Number and proportion of participants with ≥1 serum laboratory value outside the age-appropriate normal range during the study period. Laboratory values assessed include sodium, potassium, calcium, magnesium, phosphorus, glucose, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and direct bilirubin. Participants with one or more abnormal values will be counted once in this outcome.

Other outcomes

  1. Provider Satisfaction

    Time frame: 10 months

    System Usability Scale (SUS) score and post-study survey assessing provider experience (both on a 1 to 5 scale with 5 being the highest) with the AI-assisted TPN ordering system.

Study contacts

Contact information is provided by the study sponsor or research team.

Chandra Vikram, Bachelor

CONTACT

[email protected]

317-724-2159

Thanaphong Phongpreecha, PhD

CONTACT

[email protected]

551-482-4827

Sponsors and collaborators

Lead sponsor

Takeoff41, Inc.

Industry

Collaborators

  • Stanford University

Registry information

Official study title

Clinical Decision Support for Total Parenteral Nutrition Constituents in Neonatal Intensive Care Unit (NICU) Patients: A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 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.

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