Actively Recruiting

Phase Not Applicable
Age: 0 - 6Months
All Genders
ID07414576

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

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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

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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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