- Who is conducting this study?
- The MOONRISE study is conducted by Dr. Bruce German PhD, Dr. Jennifer Smilowitz PhD and Erin Ford in the Department of Food Science and Technology at UC Davis, in collaboration with Dr. Kara Kuhn-Riordon MD and colleagues at the UC Davis Medical Center. This study has been reviewed and approved by the UC Davis Institutional Review Board.
- What is the purpose of this study
- This study aims to determine if supplementing mothers of preterm infants with a vitamin B3 derivative-- nicotinamide riboside-- is effective in increasing milk production compared to a placebo. Mothers will be randomized to receive either the study supplement for the first 7-day intervention period and then a placebo for the second 7-day intervention period, or vice versa. We will assess how supplementation influences expressed milk volume, maternal metabolism, and infant development.
- Who is eligible to participate?
- * Mothers who have delivered an infant that is less than or equal to 32 weeks
* Mothers who intend to provide breast milk to their preterm infant
* Mothers willing to express and measure their breast milk
* Infants born at the UC Davis Medical Center or transferred within the first 7 days of life - Who is NOT eligible to participate?
-
* Infants participating in an intervention trial that could influence growth, development, or feeding tolerance
* Mothers who have previously undergone breast surgery or have experienced other breast trauma
* Mothers actively using narcotics or amphetamines
* Mothers receiving cancer treatment
* Mothers receiving lithium or gold therapies
* Mothers planning to use any form of lactation medication or supplement (including fenugreek)
* Mothers taking any form of hormonal contraceptive or planning to resume use within four weeks of delivery
* Mothers who are involuntarily confined
* Mothers who are unable to consent
* Mothers who were pregnant with more than one baby
* Mothers who are feeding their breast milk to another child
* Mothers whose temporary residence while their babies are receiving care is greater than >50 miles from UC Davis Medical Center - What is expected of me during the study?
- This study will last approximately four weeks in total, throughout which you will be asked to consume the provided supplement for two 7-day periods; collect and measure 24-hour breast milk volume throughout the same two 7-day periods; collect urine samples; and complete daily study notebook entries. You will also be asked to complete three questionnaires about your health and reproductive history; lifestyle; and experience in participating in the study. You will be fitted for a breast shield and instructed on the use of a hospital-grade breast pump by study personnel. You will be asked to store samples in your home fridge or freezer until transport to the UC Davis Medical Center NICU. It will be necessary for you to return frequently to the NICU for study visits and to deliver expressed breast milk.
- Will I be compensated for participation?
- Yes. Participants may receive up to $60 in Target gift cards upon completion of the study. Participants will be provided professional lactation support and will be lent a Medela Symphony®️ breast pump to use free-of-charge during the study. Mothers will also receive a complimentary a hands-free pumping bra and pumping supplies. Parking at the UC Davis Medical Center is complimentary during the five study visits.
- Who is funding this project?
- This project is funded in collaboration with donations by ChromaDex who is providing the study supplement and Medela who is donating the hospital-grade breast pumps and pumping kits for use in the study. Additional funds include 2020 Chancellor’s Innovation Awards and other departmental funds.
