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Breast Milk Collection clinical trials

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NCT ID: NCT06342674 Not yet recruiting - Breast Feeding Clinical Trials

Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients

The
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns. no effect on the infant's growth parameters and nutrient absorption levels by the infant. Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants. Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants. Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants. Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk.

NCT ID: NCT06203041 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Sulfates in Breastmilk

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.

NCT ID: NCT06182449 Not yet recruiting - Anxiety Clinical Trials

Virtual Reality Distraction for Maternal Milk Expression (PILOT)

VR-MOM
Start date: January 6, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06052592 Completed - Clinical trials for Breast Milk Collection

Metabolomic Profile in Breastfed Late Preterm Infants

Start date: March 1, 2022
Phase:
Study type: Observational

Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.

NCT ID: NCT05989009 Recruiting - Clinical trials for Breast Milk Collection

Analysis of Lipids in Human Milk at Different Gestational Ages

Start date: March 1, 2022
Phase:
Study type: Observational

Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.

NCT ID: NCT05986539 Not yet recruiting - Infant Development Clinical Trials

Early Life Feeding Exposure and Infant Immune and Health Status.

Start date: February 5, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT05943847 Recruiting - Clinical trials for Breast Milk Collection

Neurotrophic Growth Factors in Breast Milk

Start date: March 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years. The main questions it aims to answer are: - Does the breast milk of mothers with 18-month-old babies contain Brain-Derived Neurotrophic Factor (BDNF), S100B protein and glial cell line-derived neurotrophic factor (GDNF)? - Does the breast milk continue to contain BDNF, s100B protein and GDNF and-after 24 months? Participants will be asked to give breastmilk at 3 separate times. Breast milk samples will be collected from mothers at 18th-month, 24th-month and ≥25 months of their babies. A total of 75 breast milk samples obtained from 25 mothers with their consent will be analyzed.

NCT ID: NCT05745922 Recruiting - Clinical trials for Overweight and Obesity

Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity

YT
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days.

NCT ID: NCT05742815 Active, not recruiting - Clinical trials for Breast Milk Collection

Analysis of Donor Milk

DOME
Start date: August 1, 2022
Phase:
Study type: Observational

The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America

NCT ID: NCT05700162 Enrolling by invitation - Clinical trials for Mother-Infant Interaction

The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

The study was planned to determine the effect of showing photographs, videos and live images of premature babies who could not be breastfed in the neonatal intensive care unit to their mothers on the amount of breast milk, mother-infant attachment and breastfeeding self-efficacy. It is a randomized controlled experimental study.