Actively Recruiting
Clinical Decision Support for Total Parenteral Nutrition in Neonatal Intensive Care Unit Patients: A Pilot Study
Led by Takeoff41, Inc. · Updated on 2026-02-17
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Takeoff41, Inc.
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI) tool designed to assist doctors in ordering total parenteral nutrition (TPN) for newborns and infants in the neonatal intensive care unit (NICU). Premature babies who cannot eat by mouth often need nutrition delivered through an IV, but ordering TPN is complex and prone to errors. This pilot study aims to assess whether the AI tool can improve the TPN ordering process by suggesting formulas based on each baby's lab values and health data, while doctors retain full control over final decisions. The study involves two periods: in the first, doctors use the current standard practice to order TPN without AI assistance; in the second, they use the AI-driven TPN decision support tool integrated within the electronic health record system. This tool recommends TPN compositions using patient lab results, age, weight, gestational age, and physician inputs. Doctors can accept, modify, or reject the AI suggestions. The study plans to enroll about 260 neonates who require TPN, typically for around 14 days. During participation, babies will have daily lab tests and continuous monitoring of health outcomes such as weight changes, days on TPN, and common complications in premature infants. Researchers will measure how often doctors accept AI recommendations, the time taken to complete TPN orders, and clinical outcomes including lung disease, brain bleeding, infections, and other conditions. Provider satisfaction and lab value abnormalities will also be tracked. The AI tool aims to support doctors without changing standard care practices, and each baby remains in the study while receiving TPN.
CONDITIONS
Brief Title
AI-driven Total Parenteral Nutrition Platform
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns or infants needing total parenteral nutrition (TPN) in a neonatal ICU with daily lab tests
- Age up to 6 months at admission
- Any gestational age or birthweight
- Any race or sex
You will not qualify if you...
- Infants considered unfit for AI-suggested TPN by physicians due to safety concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 months
Participants receive TPN orders with or without AI-driven decision support integrated into the clinical workflow. Providers use the AI tool to guide TPN composition or follow standard practice, with final prescribing authority remaining with providers.
Daily assessments during hospitalization
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
T
Thanaphong Phongpreecha, PhD
C
Chandra Vikram, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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