Not Yet RecruitingPhase 2/3

Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants

United States40 participantsStarted 2026-06-01

Plain-language summary

This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria are required to be met before or at enrollment: Mothers who are 18 years or older. Infants delivered at 24-32 weeks OR infants (any GA) that researchers anticipate will be hospitalized in the NICU for at least 4 weeks, including, but not limited to, infants with a diagnosis of gastroschisis, a cardiac defect, intestinal atresia, etc. Infants born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 7 days of life. Mothers who attempted initial milk expression within 12 hours of delivery. Mothers who attempted milk expression at least 6 times every 24 hours from 72 hours after delivery to the Enrollment Visit. Mothers who have delivered at least 96 hours (4 days) prior to the Enrollment Visit. Mothers who have experienced a level "3" on the OMPQ before starting the collection of their first 24-hour pooled milk sample (study days 0-3). Mothers who plan to feed their infants breast milk for at least 3 months. Mothers who were pregnant with one infant. Mothers willing to refrain from tandem feeding (directly breastfeeding) another child during the study period. Mothers willing to refrain from enrolling themselves in another intervention trial during the study period. Mothers willing to express, weigh, record, and collect 24-hour pooled milk Mothers willing to remove nipple piercings during the study period. Mothers willing to refrain from using pseudoephedrine (often found in Sudafed, Theraflu, Clariti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of enrollment in a double-blind placebo-controlled supplementation trial in mothers of infants who are hospitalized.

Timeframe: Within 4 days post-delivery of the infant.

Trial details

NCT IDNCT04614714

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Nicole Cacho, DO

916-619-6081 ntcacho@ucdavis.edu

View on ClinicalTrials.gov More Preterm Birth trials