AI-guided IV nutrition for newborns in the NICU
Official title: Clinical Decision Support for Total Parenteral Nutrition Constituents in Neonatal Intensive Care Unit (NICU) Patients: A Pilot Study
Run by Takeoff41, Inc. · NCT07414576 · Data updated 2026-11-12
This project will try an AI tool that suggests IV nutrition (TPN) for newborns in the NICU who cannot feed by mouth to see if it helps clinicians order the right formula more quickly and accurately.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 6 Months |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Takeoff41, Inc. Industry-sponsored |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | February 21, 2027 |
| Study ends | February 21, 2027 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07414576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Newborns and infants up to about 6 months old admitted to a NICU who require total parenteral nutrition and receive daily laboratory testing are the intended participants.
✕Probably not a fit
Infants whose treating physicians judge the AI recommendations unsafe, those not receiving daily lab monitoring, or infants treated outside the participating NICU are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot deploys an AI-driven clinical decision support tool that suggests prebuilt TPN units for each infant based on daily labs, demographics, and decades of prior data; clinicians can accept, modify, or reject suggestions at any time. The main measure is how often physicians accept the AI recommendations, with secondary outcomes including time to complete TPN orders, weight z-score change, days on TPN, lab abnormalities, provider satisfaction, and a composite morbidity index of common preterm complications. The study plans to enroll about 260 neonates admitted to a participating NICU and will operate within usual care workflows to minimize disruption. The platform is provided by Takeoff41, Inc. in collaboration with Stanford University and will be used at Stanford's NICU site.
Why it matters
Potential benefit: If successful, the tool could reduce ordering errors, save clinician time, and help provide more consistent, individualized nutrition that may improve growth and reduce complications.
How similar studies have gone: AI clinical decision support has improved ordering efficiency in some other clinical areas, but AI-guided neonatal TPN is a novel application that has not been tested at scale.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Stanford University
Stanford, California, United States Recruiting
Study contacts
- Principal investigator: David Stevenson, MD — Stanford University
- Study coordinator: Thanaphong Phongpreecha, PhD
- Email: joe@takeoff41.com
- Phone: 551-482-4827
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.