Retrospective Cohort Study Demonstrates Tolerance and Adherence to Pea-Based Complete Enteral Formula When Transitioned from a Previous Hypoallergenic Product.

Background: Plant-based formulas have become increasingly popular due to their health benefits, environmental concerns, cultural beliefs, improved palatability, and decreased cost. A retrospective chart review of medically stable children transitioning from a hypoallergenic formula to a yellow pea protein plant-based formula (PPPBF) was included. This study aimed to assess gastrointestinal tolerance, weight changes, and adherence to receiving a unique PPPBF.

A Narrative Review of Strategies to Optimize Nutrition, Feeding, and Growth among Preterm-Born Infants: Implications for Practice.

Preterm birth is the leading cause of neonatal and under-5 mortality globally, and healthcare-related burden and nutrition-related morbidities are unsustainable, particularly in resource-limited regions. Additionally, preterm infants are susceptible to multiple adverse outcomes including growth faltering, suboptimal neurodevelopment, and multisystemic morbidities. Maturation, healing, repair, and restoration to normalcy in preterm-born infants require optimizing nutrition; only then, prognosis, growth, neurodevelopment, and overall quality of life can improve.

DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation.

Purpose: To investigate the relationships among docosahexaenoic acid (DHA) intake, nutrient intake, and maternal characteristics on pregnancy outcomes in a phase III randomised clinical trial designed to determine the effect of a DHA dose of 1000 mg/day compared to 200 mg/day on early preterm birth (<34 weeks gestation).

Methods: A secondary aim of the phase III randomised trial was to explore the relationships among pregnancy outcomes (maternal red blood cell phospholipid (RBC-PL) DHA at delivery, preterm birth, gestational age at delivery, labor type, birth anthropometric measures, low birth weight, gestational diabetes, pre-eclampsia, and admission to a neonatal intensive care unit) in participants (n = 1100). We used Bayesian multiple imputation and linear and logistic regression models to conduct an analysis of five general classes of predictor variables collected during the trial: a) DHA intake, b) nutrient intake from food and supplements, c) environmental exposure to tobacco and alcohol, d) maternal demographics, and e) maternal medical history.

Micronutrient Gaps and Supplement Use in a Diverse Cohort of Pregnant Women.

Background: Micronutrition in pregnancy is critical to impact not only fetal growth and development but also long-term physical and psychiatric health outcomes.

Objective: Estimate micronutrient intake from food and dietary supplements in a diverse cohort of pregnant women and compare intake to the Dietary Reference Intakes (DRIs).

Design: Secondary analysis of women enrolled in a multi-site clinical trial of docosahexaenoic acid (DHA) supplementation who provided their dietary intake using the diet history questionnaire-II ( = 843) or multiple 24 h recalls ( = 178) at baseline and their intake of nutritional supplements at baseline through 30 days postpartum.

Perceptions of the impact of a multidose human-milk fortifier on human-milk preparation practices in United States neonatal intensive care units: A survey of nutrition care team members.

Background: In 2020, a multidose human-milk fortifier (MDHMF) was designed to improve the process of human-milk (HM) fortification. The bottle of MDHMF (5.5 oz, 163 ml) allows aseptic removal of HMF in a precise measure.

The value of a two-armed Bayesian response adaptive randomization trial.

We investigate the value of a two-armed Bayesian response adaptive randomization (RAR) design to investigate early preterm birth rates of high versus low dose of docosahexaenoic acid during pregnancy. Unexpectedly, the COVID-19 pandemic forced recruitment to pause at 1100 participants rather than the planned 1355. The difference in power between number of participants at the pause and planned was 87% and 90% respectively.

Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth.

Pregnancy and parturition involve extensive changes in the maternal immune system. In our randomized, multi-site, double-blind superiority trial using a Bayesian adaptive design, we demonstrated that 1000 mg/day of docosahexaenoic acid (DHA) was superior to 200 mg/day in preventing both early preterm birth (less than 34 weeks' gestation) and preterm birth (less than 37 weeks' gestation). The goal of this secondary study is to compare the effects of 1000 mg/day versus 200 mg/day on maternal inflammation, a possible mechanism by which DHA may prevent preterm birth.

The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study.

Background: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses.

Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial.

Background: Several meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (EPB, < 34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.

Methods: This randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres.

A Randomized Trial of Maternal Docosahexaenoic Acid Supplementation to Reduce Inflammation in Extremely Preterm Infants.

Maternal supplementation with 1000 mg/day docosahexaenoic acid (DHA) provides third trimester DHA accretion levels in breast milk for the preterm infant. We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would result in decreased inflammatory markers, in the infant. Mother/infant dyads (n = 27) were enrolled at birth and mothers were assigned to receive 200 or 1000 mg/day of DHA.

Nutrition Support Team Guide to Maternal Diet for the Human-Milk-Fed Infant.

Background: Human milk feeding is encouraged for all infants; however, the mammary gland depends on maternal dietary intake of vitamins A, B1, B2, B6, B12, D, docosahexaenoic acid (DHA), choline, and iodine. Nutrition support team knowledge of maternal feeding guidelines for these nutrient sources can therefore impact infant intake. We hypothesized that these key nutrients for lactation in the mother's diet would be less than the dietary guidelines in the United States.

Lactational Stage of Pasteurized Human Donor Milk Contributes to Nutrient Limitations for Infants.

Background: Mother's own milk is the first choice for feeding preterm infants, but when not available, pasteurized human donor milk (PDM) is often used. Infants fed PDM have difficulties maintaining appropriate growth velocities. To assess the most basic elements of nutrition, we tested the hypotheses that fatty acid and amino acid composition of PDM is highly variable and standard pooling practices attenuate variability; however, total nutrients may be limiting without supplementation due to late lactational stage of the milk.

Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol.

Background: Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (<34 weeks) (ePTB), which has decreased little since 1990 and has the greatest impact on the overall infant mortality, resulting in the greatest cost to society.

Comparison of enteral feeding of preterm infants between two hospitals in China and United States.

Aim: To compare the details of preterm infants enteral feeding between the two hospitals in China and in the United States, and to analyze the reason of the differences.

Methods: A retrospective cohort study was conducted. Infants < 32 weeks were enrolled from Cincinnati University Hospital (CUH) during January 2011 to January 2012 and Peking Union Medical College Hospital (PUMCH) during January 2011 to May 2012.

A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market.

The American Society for Parenteral and Enteral Nutrition (A.S.P.

Neonatal Body Composition: Measuring Lean Mass as a Tool to Guide Nutrition Management in the Neonate.

Neonatal nutrition adequacy is often determined by infant weight gain. The aim of this review is to summarize what is currently known about neonatal body composition and the use of body composition as a measure for adequate neonatal nutrition. Unlike traditional anthropometric measures of height and weight, body composition measurements account for fat vs nonfat mass gains.

Role of perinatal long-chain omega-3 fatty acids in cortical circuit maturation: Mechanisms and implications for psychopathology.

Accumulating translational evidence suggests that the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) plays a role in the maturation and stability of cortical circuits that are impaired in different recurrent psychiatric disorders. Specifically, rodent and cell culture studies find that DHA preferentially accumulates in synaptic and growth cone membranes and promotes neurite outgrowth, dendritic spine stability, and synaptogenesis. Additional evidence suggests that DHA may play a role in microglia-mediated synaptic pruning, as well as myelin development and resilience.

Safety and Tolerability of Enteral Protein Supplementation for Infants With Brain Injury.

Background: We hypothesized that enteral protein supplementation in infants with brain injury would be safe and well tolerated and improve growth.

Materials And Methods: Twenty-five infants with perinatal brain injury were randomized to a high-protein (4 g/kg/d) or standard-protein diet and followed for 12 months.

Results: The whey protein powder was well tolerated by 9 of the 13 infants in the high-protein group, and no adverse events related to the supplement were seen.

[Comparison of feeding pattern of preterm infants between two hospitals in China and the United States].

Objective: To compare the feeding pattern of preterm infants between two hospitals in China and the United States.

Methods: A retrospective cohort study was conducted. Infants <32 weeks were enrolled from Cincinnati Children's Hospital Center Cincinnati University Hospital (CCHMC group) between January 2011 and January 2012 and Peking Union Medical College Hospital (PUMCH group) between January 2011 and May 2012.

Neonatal therapeutic hypothermia-associated hypomagnesemia during parenteral nutrition therapy.

Background: Hypoxic-ischemic encephalopathy (HIE) is a significant cause of morbidity and mortality in the neonatal population. Total body cooling in term infants who meet the criteria for moderate to severe HIE has been shown to be neuroprotective. A decreased core body temperature is known to affect kinetic properties of many enzyme systems in which magnesium is a cofactor.