19 Clinical Trials for Various Conditions
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values \< 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes. The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day. The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age. Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
Aim 1: Assess directional signal of effect of fortified salt with folic acid and iodine on blood serum folate levels. It will be accomplished by feasibility pre-test/post-test clinical study by estimating mean and variability of serum blood folate levels effects of folic acid fortified salt. Hypothesis: Fortified salt with folic acid and iodine will increase serum blood folate levels from baseline by month 1. Aim 2: Assess feasibility and acceptability of salt fortified with folic acid and iodine. Feasibility will be measured by 1) subjects' refusal rate of consent by 30 subjects during 6-month enrollment period; 2) method of determining salt consumption (weighting the saltshaker pre and post); 3) completion rates of study protocols from baseline to follow up. Hypothesis 1a: Completion of all blood draw visits will be 90-100%. Acceptability will be measured by 1) completion rate of daily salt logs; 2) consumption of salt by weighting saltshakers; 3) attitude towards taste and color difference. Hypothesis 1b: Completion rate (90-100%) of daily salt logs will range from 90-100% of participants and 2) consumption of salt will range from 90-100% of participants. Dietary surveys will be employed to document dietary habits and estimated daily FA intake in the sample population. Feasibility and acceptability of dietary surveys will be measured by willingness to answer survey questions. Hypothesis 1c: Completion rate of dietary surveys will range 90-100%.
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project. The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program\* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment. Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques. Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived nutrition.
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories. This product is made from donor human milk from which the skim (non-lipid portion) has been separated and then concentrated. A certain amount of the lipid content has been added back to achieve higher caloric content within a small delivery volume. The product is then pasteurized and filled in small quantities in order to allow for the addition of mother's own milk (or, possibly, milk from another donor). The goal of the preparation is to achieve an increase of approximately 4 cal/oz of mother's milk and to provide a protein level (when mixed with average pre-term milk) of about 3.5-3.8 g/100 Kcal of feed. The data on Prolact-Plus will be obtained prospectively from infants who will receive human milk fortified in this fashion. The data on standard,bovine (cow)-fortified milk will be obtained retrospectively from medical records at the participating institutions. While this design is not necessarily optimal in this setting, it is an efficient and quick approach to evaluating the acute clinical effect of Prolact-Plus. It is anticipated that further studies will be conducted that will examine longer-term accounts and possibly do this in a controlled, randomized environment. The goal of this study is to evaluate the short-term effect of Prolact-Plus fortified human milk when compared with bovine-based fortification of human milk on parameters such as growth and short-term development, infectious complications and incidence of feeding intolerance in a cohort design. Statistically, the study will attempt to evaluate a null hypothesis of equivalent results with respect to these parameters between the two types of fortifiers as compared with a two-sided alternative (difference between the groups). In addition, data will be collected on overall survival and length of stay in the NICU. These data will be collected for descriptive purposes, although an attempt will be made to compare the findings with those obtained from the bovine-based fortifier.