Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT04614714

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

Conditions: Preterm Birth, Inadequate Milk Production

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2, PHASE3
Enrollment: 40
Sponsor: University of California, Davis

Location: University of California, Davis Sacramento California

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.

Eligibility Criteria

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, Claritin-D, etc.) during the study period. Mothers willing to express milk 6 times or more every 24 hours, including at least once during the night, and with no more than 5 hours between milk expression sessions, during the study period. Mothers willing to refrain from consuming non-study supplements that contain nicotinamide-riboside (or similar derivatives, including NMN) during the study period. Mothers willing to refrain from consuming galactagogues during the study period.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04614714). StuddyBuddy aggregates publicly available trial information.