An interventional study of AI-driven total parenteral nutrition (TPN) in Intestinal Failure, sponsored by Takeoff41, Inc.. Recruiting at 1 site in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Takeoff41, Inc. · Not applicable, Interventional, and Health services research
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 260 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →This is the only study on the registry with Takeoff41, Inc. as lead sponsor.
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Exclusion Criteria:
- Infants deem unfit for the suggested TPN due to safety concerns by physicians
Patients admitted during Period 1. Providers use current standard TPN ordering practice without AI assistance. Serves as baseline comparison.
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).
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.
Time frame: 10 months
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.
Time frame: 10 months
Days on TPN
Number of days the infants have to get TPN
Time frame: 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.
Time frame: 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.
Time frame: 10 months
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.
Time frame: 10 months
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Feb 2027, 13 months after the start.
Of 17 interventional studies with no phase under Intestinal Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 13 months is below that.
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