Breast Milk Collection

5

Review clinical trials related to Breast Milk Collection. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Virtual Reality Distraction for Maternal Milk Expression (PILOT)

Background In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. This practice is promoted by nurses and neonatologists due to its beneficial outcomes for newborns. Compared to newborns exclusively fed commercial infant formula, preterm newborns fed breast milk (BM) are less likely to suffer from necrotizing enterocolitis and late-onset sepsis. However, the discomfort associated with using an electrical pump may discourage its use, and almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress. Therefore, virtual reality (VR), an immersive experience, seems to be an interesting option as it would provide a relaxing environment and distract mothers of newborns in NICU from the stress and discomfort experienced in order to promote breast milk expression. Aim The aim of this within-subject, pilot clinical trial is to assess the feasibility, acceptability, and preliminary effects of VR on stress, discomfort, and volume of expressed milk in mothers of preterm newborns. Methods Design: Within-subject, randomized pilot clinical trial in which participants are their own control. Setting and sample: Level 3 neonatal intensive care unit (NICU) at a Montreal pediatric teaching university center. Newborns under 29 weeks of age were chose to ensure that newborns would be admitted and remain in the NICU. The objective is to recruit 20 mothers of premature newborns. This will correspond to a total sample of 40 participants as they will be their own control. There will be 50% more mothers recruited (10) to compensate for the usually high attrition or rejection rate for this population, thus a total sample of 30 mothers. Healthcare professionals (nurses and doctors) providing care to participating mothers will be asked to fill a questionnaire on the feasibility of the VR intervention. Randomization and exposure to the interventions: The sequence of exposure to VR will be randomized, not the participants: sequence of 2 days with VR and 2 days without VR. The study will take place over the course of one week. Participating mothers will either be exposed to VR for a minimum of 2 sessions of 30 minutes/day for two days and the following two days to the control intervention or the opposite.

Participants needed: 20
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: St. Justine's HospitalUpdated: Aug 24, 2025Locations: 1
Eligibility criteria

speak and read French or English [+4]

Having a mental health problem or a significant cognitive disorder that prevents... [+1]

Status: Recruiting

Excretion of Rivaroxaban in Human Breast Milk

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

Participants needed: 10
Trial details
Phase: Phase 1Age: 18+Biological sex: FemaleType: InterventionalSponsor: Thomas Jefferson UniversityUpdated: Jul 17, 2025Locations: 1
Eligibility criteria

Postpartum within 6 weeks of delivery [+7]

Pregnant [+8]

Status: Recruiting

Mother-Infant Cohort Study in Malaysia and China

This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development. It also aims to determine the impact of gut microbiome on infant health (temperament, gastrointestinal symptoms, eczema symptoms, and asthma symptoms).

Participants needed: 200
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: Universiti Putra MalaysiaUpdated: Dec 13, 2024Locations: 1
Eligibility criteria

Pregnant women aged between 18 and 45 years old [+3]

Pregnant women who are diagnosed with immune deficiency [+3]

Status: Recruiting

Early Life Feeding Exposure and Infant Immune and Health Status.

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

Participants needed: 60
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University of IdahoUpdated: Jul 26, 2024Locations: 1
Eligibility criteria

Mother at least 18 years of age [+7]

Mother or Infant have participated or are currently participating in an interven... [+3]

Status: Recruiting

Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.

Participants needed: 100
Trial details
Age: Up to 40Biological sex: AllType: ObservationalSponsor: Zhujiang HospitalUpdated: Jul 25, 2023Locations: 1
Eligibility criteria

healthy pregnant women aged between 20y and 40y. [+3]

gestational diabetes [+6]