Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely… (NCT04614714) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
United States40 participantsStarted 2026-04-01
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 range18 Years
SexFEMALE
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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…
What they're measuring
1
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.