Opportunities - Comparing impacts of donor human milk to formula supplement of full-term infants who are born via caesarean section: A patient-oriented, clinical pilot randomized controlled trial
Comparing impacts of donor human milk to formula supplement of full-term infants who are born via caesarean section: A patient-oriented, clinical pilot randomized controlled trial
University of Calgary, Faculty of Nursing
The infant gut microbiome is established in the first months of life and plays an important role in brain, gut, and immune systems development. Early-life disruptions to the developing gut microbiome from exposures such as antibiotic therapy and caesarean section delivery can lead to long-term adverse child health outcomes including allergies, obesity, and neurodevelopmental disorders. While exlusive breastfeeding can help repair the gut microbiome in babies who experience disruptions to their microbiome, 40-60% of babies end up requiring formula supplementation in their first few weeks of life, which can further disrupt the microbiome. Donor human milk (DHM) may be an excellent alternative to formula supplementation because it has components that are beneficial to the developing infant gut microbiome.
In this patient-oriented, clinical trial, we will compare the impacts of DHM to formula supplementation on the gut microbiome of full-term infants who are born via caesarean section, to determine if using DHM is linked to improvements in their microbiome. We plan to co-identify the secondary outcomes (infant and maternal health outcomes) with patient research partners. We are looking for parents who have lived experience donating their own breast milk to a milk bank, parents who have used donor human milk (DHM) for their full-term infant, and parents who have had to supplement their full-term infant after a caesarean section delivery. By incorporating these parent perspectives, insights and experiences, we aim to enhance the meaningfulness and utility of our research that will result in improved health outcomes.
Roles and Responsibilities
We are asking for people with this lived experience to join our patient/parent advisory committee (PAC). We are looking for Alberta parents who have lived experience donating their own breast milk to a milk bank, parents who have used donor human milk (DHM) for their full-term infant, and parents who have had to supplement their full-term infant after a caesarean section delivery. This committee will meet monthly and members will be asked to identify research outcomes around donor human milk (DHM) use, infant and maternal health outcomes, and issues around equitable access to DHM. PAC members will also be asked to help co-develop participant recruitment strategies, provide feedback on the acceptability of the intervention (DHM) and how it is provided, interpret results and co-develop knowledge translation and dissemination strategies.
This project aims to start in Calgary, AB in September 2023 and will last for approximately 18 months. We expect to meet once per month. Early in the study design, we may meet more frequently. The first meeting will be in person in Calgary and should last about 3-4 hours. Subsequent meetings will be offered as a hybrid style (virtual and in-person) and will likely be 1-2 hours.
Patient/parent advisory committee members will be offered compensation for their time at $25/hour. In addition to time compensation, funding will be available for dependent care and reimbursement for direct travel costs associated with attending in-person meetings. Paid training opportunities will also be offered.
For more information or to apply