AI-driven Total Parenteral Nutrition Platform

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Failure
• Intervention / Treatment: Device: AI-driven total parenteral nutrition (TPN)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thanaphong Phongpreecha, PhD; Phone Number: 551-482-4827; Email: joe@takeoff41.com
• Study Contact Backup: Name: Chandra Vikram, Bachelor; Phone Number: 317-724-2159; Email: chandra101@takeoff41.com

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Thanaphong Phongpreecha, PhD; Phone Number: 551-482-4827; Email: joe@takeoff41.com
      • Contact: Barbara Chargin; Phone Number: 650-723-7222; Email: bchargin@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard TPN Ordering (Control); Patients admitted during Period 1. Providers use current standard TPN ordering practice without AI assistance. Serves as baseline comparison.
Experimental: AI-driven total parenteral nutrition (TPN); Patients admitted during Period 2. Providers use the AI-assisted TPN decision support tool integrated with Epic to order TPN. Providers may opt out and use traditional ordering if needed.	Device: AI-driven total parenteral nutrition (TPN); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Acceptance Rate	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.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight Z-Score	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.	10 months
Days on TPN	Number of days the infants have to get TPN	10 months
Composite Clinical Outcome	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.	13 months
Rate of Laboratory Value Abnormalities	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.	10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Satisfaction	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.	10 months

Collaborators and Investigators

• Sponsor: Takeoff41, Inc.
• Collaborators: Stanford University
• Investigators: Principal Investigator: David Stevenson, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): February 21, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: parenteral nutrition
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intestinal Failure; Hyperphagia
• Other Study ID Numbers: 74413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of individual participant data, even de-identified, is subject to approval by the Stanford Privacy Office and Institutional Review Board (IRB), and requests will be considered on a case-by-case basis. General summary statistics of the study population and aggregate results will be shared through peer-reviewed manuscript publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No