AI-driven Total Parenteral Nutrition Platform

ConditionIntestinal Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 6

SponsorTakeoff41, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

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).

Treatment groups

260 Participants

are divided into 2 treatment groups

Group A: Standard TPN Ordering (Control)No intervention 0 interventions

Group B: AI-driven total parenteral nutrition (TPN)Experimental treatment 1 intervention

Trial outcomes

Primary 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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Takeoff41, Inc.

Lead sponsor

Stanford University

Collaborator

Source ClinicalTrials.gov

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