A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU.
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ABSTRACT:
SUBMITTER: Sun H
PROVIDER: S-EPMC7014600 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
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A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU.
Sun Huiqing H Cao Yun Y Han Shuping S Cheng Rui R Liu Ling L Liu Jiangqin J Xia Shiwen S Zhang Jiajie J Li Zhankui Z Cheng Xiuyong X Yang Chuanzhong C Pan Xinnian X Li Long L Ding Xin X Wang Rensheng R Wu Mingyuan M Li Xiaoying X Shi Liping L Xu Falin F Yu Fengqin F Pan Jiahua J Zhang Xiaolan X Li Li L Yang Jie J Li Mingxia M Yan Changhong C Zhou Qi Q Lu Jiao J Wei Mou M Wang Laishuan L Yang Ling L Ye Xiang Y XY Unger Sharon S Kakulas Foteini F Lee Shoo K SK
Trials 20200211 1
<h4>Background</h4>Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at < 30 weeks' gestation. The incidence of NEC is reduced when infants are fed human milk. However, in many neonatal intensive care units (NICUs), it is standard practice to freeze and/or pasteurize human milk, which deactivates bioactive components that may offer additional protective benefits. Indeed, our pilot study showed that one feed of fresh mother's own milk per day was safe, feasi ...[more]
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Project description:Necrotizing enterocolitis (NEC) is the leading cause of death among infants born at <30 weeks' gestation, but donor human milk can reduce the incidence of NEC. Unfortunately, freezing or pasteurizing human milk deactivates beneficial bioactive components. We evaluated the feasibility, safety, and impact of feeding very preterm infants fresh (unprocessed) mother's own milk within 4?hours of expression. In our multicentre prospective cohort analytic study, we fed 109 control and 98 intervention infants previously frozen donor or mother's own milk; only the intervention group was fed fresh mother's own milk once daily from enrollment until 32 weeks' corrected age. Control group mothers could not commit to provide fresh milk daily and were less likely receive antenatal corticosteroids than mothers in the intervention group. In the intervention group, 87.5% (98/112) of mothers were able to provide at least one feed of fresh milk a day. No critical incidents or non-compliance with the protocol were reported. The duration of mechanical ventilation and total parenteral nutrition use were shorter in the intervention group than controls (P?<?0.01) but the length of hospital stay was similar (P?=?0.57). Although the study might be underpowered, the intervention group had lower unadjusted rates of the composite outcome NEC???stage 2 or mortality (8% vs 20%, P?=?0.04), sepsis (22% vs 38%, P?=?0.02), retinopathy of prematurity (17% vs 39%, P?<?0.01) and bronchopulmonary dysplasia (32% vs 47%, P?<?0.01) than the control. These results indicated that feeding fresh mother's own milk once daily was safe, feasible, and may reduce morbidity.
| S-EPMC6353969 | biostudies-literature
Project description:There are no specific recommendations for using a mother's fresh milk for her preterm infant. We reviewed the available evidence on its collection, storage and administration.The working group of the French Neonatal Society on fresh human milk use in preterm infants searched the MEDLINE database and Cochrane Library up to June 2017 for papers published in English or French. They specifically analysed 282 papers providing information on prospective, retrospective and clinical studies and examined guidelines from various countries.The review concluded that fresh mother's own milk should be favoured in accordance with the latest recommendations. However, it must be carried out under stringent conditions so that the expected benefits are not offset by risks related to different practices. The working group has summarised the best conditions for feeding preterm infants with human milk, balancing high nutritional and immunological quality with adequate virological and bacteriological safety. Professionals must provide parents with the necessary conditions to establish breastfeeding, together with specific and strong support.Based on their review, the working group has made specific recommendations for using fresh mother's own milk under careful conditions, so that the expected benefits are not offset by risks related to practices.
| S-EPMC6032854 | biostudies-other
Project description:The influence of types of human milk (HM)-raw own mother's milk (OMM), pasteurized OMM, and donor milk (DM)-was evaluated for growth in premature infants fed exclusively HM with controlled nutritional intakes using daily individualized HM fortification (IHMF). Growth and nutritional intakes were prospectively collected in preterm infants (<32 weeks) fed IHMF and compared in infants fed predominantly (?75%) OMM and DM. The influence of HM types (raw OMM, pasteurized OMM, and DM) on growth were also evaluated in the whole population. One-hundred and one preterm infants (birth weight 970 ± 255 g, gestational age 27.8 ± 1.9 weeks) were included. Energy (143 ± 8 vs. 141 ± 6 kcal/kg/day; p = 0.15) and protein intakes (4.17 ± 0.15 vs. 4.15 ± 0.14 g/kg/day; p = 0.51) were similar in both groups. Infants receiving predominantly OMM (n = 37), gained significantly more weight (19.8 ± 2.0 vs. 18.2 ± 2.2 g/kg/day; p = 0.002) and length (1.17 ± 0.26 vs. 0.99 ± 0.36 cm/week; p = 0.020) than those fed predominantly DM (n = 33). Stepwise multivariate analysis (n = 101) suggests that raw OMM was the major determinant of growth, contributing 22.7% of weight gain. Length gain was also related to OMM (raw + pasteurized) intakes, explaining 4.0% of length gain. In conclusion, at daily controlled similar protein and energy intakes, OMM had significant beneficial effects on weight and length versus DM in VLBW infants. This difference could be partially explained by the use of raw OMM.
| S-EPMC6521225 | biostudies-literature
Project description:Rationale: There is little information regarding the allergen content of milk feeds in the preterm population. Previous studies have not performed a broad analysis of the allergenic peptide content and protease activity of milk feeds in this population. Methods: To evaluate feasibility, we initially performed mass spectrometry on 4 human milk (HM) samples (2 term and 2 preterm) from the Mommy's Milk Human Milk Biorepository (HMB) and analyzed the results against the University of Nebraska FASTA database and UniProt for a total of 2,211 protein sequences. We then further analyzed five samples from the Microbiome, Atopy, and Prematurity (MAP) study including peptidomic and protease activity analysis. Results: Each HMB sample had between 806 and 1,007 proteins, with 37-44 nonhuman proteins/sample encompassing 26 plant and animal species. In the preterm MAP samples, 784 digested nonhuman proteins were identified, 30 were nonbovine in origin. Proteins from 23 different species including aeroallergens, food, and contact allergens were identified. Protease activity was highest in HM samples without human milk fortifier and lowest in preterm formula. Conclusions: These findings represent the first preterm milk feed mass spectrometry and protease analysis with identification of known allergenic proteins to food, contact, and aeroallergens. These results raise questions of whether the composition of milk feeds in the neonatal intensive care unit impact the development of atopic disease in the preterm population and whether the complex interaction between allergens, proteases, and other HM components can serve to induce sensitization or tolerance to allergens in infants. Clinical Trial Registration Number: NCT04835935.
| S-EPMC10081709 | biostudies-literature
Project description:The purpose of this is to evaluate the effect of supplementation of enteral feed volume with preterm versus term donor human milk (DHM) on short-term physical growth in very low birth weight (VLBW) neonates. In this open-label, variable block-sized, superiority, randomized controlled trial with allocation concealment, VLBW neonates with insufficient volume of mother's own milk (MOM) were assigned to receive either preterm (n = 48) or term (n = 54) DHM till discharge. Preterm DHM was defined as the breast milk expressed within 28 days of delivery at ≤ 34 weeks of gestation. The primary outcome was days to regain birth weight. Maternal and neonatal demographic variables were comparable in the two study groups. Days to regain birth weight were significantly more in the preterm DHM group, 17.4 (7.7) vs 13.6 (7.2) days, mean difference (95% CI) being 3.74 (0.48-7.0) days, P = 0.02). The proportion of MOM use was 82% in preterm vs 91.1%, P = 0.03 in the term milk group. Duration of skin-to-skin contact was also significantly lower in the preterm vs term milk group, the median (IQR) was 4 (0, 6) vs 4 (2, 6) hours/day, P < 0.01. However, bronchopulmonary dysplasia was higher in the preterm milk group (13% vs. 4%, P = 0.17). The velocity of gain in weight was similar in the two groups from week 1-3 but higher in the term DHM supplementation group during the 4th week. Conclusion: Supplementing MOM with preterm DHM did not result in a faster regaining of birth weight. Trial registration: CTRI/2020/02/023569; Date: 17.02.2020.
| S-EPMC9708515 | biostudies-literature
Project description:Mother's own milk represents the optimal source for preterm infant nutrition, as it promotes immune defenses and gastrointestinal function, protects against necrotizing enterocolitis, improves long-term clinical outcome and is hypothesized to drive gut microbiota assembly. Preterm infants at birth usually do not receive their mother's milk directly from the breast, because active suckling and coordination between suckling, swallowing and breathing do not develop until 32-34 weeks gestational age, but actual breastfeeding is usually possible as they grow older. Here, we enrolled moderately preterm infants (gestational age 32-34 weeks) to longitudinally characterize mothers' milk and infants' gut and oral microbiomes, up to more than 200 days after birth, through 16S rRNA sequencing. This peculiar population offers the chance to disentangle the differential contribution of human milk feeding per se vs. actual breastfeeding in the development of infant microbiomes, that have both been acknowledged as crucial contributors to short and long-term infant health status. In this cohort, the milk microbiome composition seemed to change following the infant's latching to the mother's breast, shifting toward a more diverse microbial community dominated by typical oral microbes, i.e., Streptococcus and Rothia. Even if all infants in the present study were fed human milk, features typical of healthy, full term, exclusively breastfed infants, i.e., high percentages of Bifidobacterium and low abundances of Pseudomonas in fecal and oral samples, respectively, were detected in samples taken after actual breastfeeding started. These findings underline the importance of encouraging not only human milk feeding, but also an early start of actual breastfeeding in preterm infants, since the infant's latching to the mother's breast might constitute an independent factor helping the health-promoting assembly of the infant gut microbiome.
| S-EPMC6204356 | biostudies-literature
Project description:Maternal antibody transfer to the newborn provides essential support for the infant's naïve immune system. Preterm infants normally receive maternal antibodies through mother's own breast milk (MBM) or, when mothers are unable to provide all the milk required, donor breast milk (DBM). DBM is pasteurized and exposed to several freeze-thaw cycles, which could reduce intact antibody concentration and the antibody's resistance to digestion within the infant. Whether concentrations of antibodies in MBM and DBM differ and whether their survival across digestion in preterm infants differs remains unknown. Feed (MBM or DBM), gastric contents (MBM or DBM at 1-h post-ingestion) and stool samples (collected after a mix of MBM and DBM feeding) were collected from 20 preterm (26-36 weeks gestational age) mother-infant pairs at 8-9 and 21-22 days of postnatal age. Samples were analyzed via ELISA for the concentration of secretory IgA (SIgA), total IgA (SIgA/IgA), total IgM (SIgM/IgM) and IgG. Total IgA, SIgA, total IgM and IgG concentrations were 55.0%, 71.6%, 98.4% and 41.1% higher in MBM than in DBM, and were 49.8%, 32.7%, 73.9% and 39.7% higher in gastric contents when infants were fed with MBM than when infants were fed DBM, respectively. All maternal antibody isotypes present in breast milk were detected in the infant stools, of which IgA (not sIgA) was the most abundant.
| S-EPMC6521323 | biostudies-literature
Project description:Objective: An increasingly common practice is to feed preterm infants a base diet comprising only human milk (HM), usually fortified with a cow's milk (CM)-derived fortifier (CMDF). We evaluated the safety of CMDF in a diet of 100% mother's own milk (MOM) against a HM-derived fortifier (HMDF). To date, this has received little research attention. Study Design: We reanalyzed a 12-center randomized trial, originally comparing exclusive HM feeding, including MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1. However, for the current study, we performed a subgroup analysis (n = 114) selecting only infants receiving 100% MOM base diet plus fortification, and fed no DM or PTF. This allowed for an isolated comparison of fortifier type: CMDF versus HMDF to evaluate the primary outcomes: necrotizing enterocolitis (NEC) and a severe morbidity index of NEC surgery or death; and several secondary outcomes. Results: CMDF and HMDF groups had similar baseline characteristics. CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 (p = 0.038), NEC surgery or death (RR 5.1, p = 0.014); and reduced head circumference gain (p = 0.04). Conclusions: In neonates fed, as currently recommended with a MOM-based diet, the safety of CMDF when compared to HMDF has been little researched. We conclude that available evidence points to an increase in adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death.
| S-EPMC7232708 | biostudies-literature
Project description:Feeding preterm infants mother's own milk (MOM) lowers rates of sepsis, decreases necrotizing enterocolitis, and shortens hospital stay. In the absence of freshly expressed MOM, frozen MOM (FMOM) is provided. When MOM is unavailable, preterm infants are often fed pasteurized donor human milk (DHM), rendering it devoid of beneficial bacteria. We have previously reported that when MOM is inoculated into DHM to restore the live microbiota [restored milk (RM)], a similar microbial diversity to MOM can be achieved. Yet, it is unknown if a similar diversity to MOM can be obtained when FMOM is inoculated into DHM. The goal of this study was to determine whether a similar microbial composition to MOM could be obtained when FMOM is used to personalize DHM. To this end, a fresh sample of MOM was obtained and divided into fresh and frozen fractions. MOM and FMOM were inoculated into DHM at different dilutions: MOM/FMOM 10% (RM/FRM10) and MOM/FMOM 30% (RM/FRM30) and incubated at 37°C. At different timepoints, culture-dependent and culture-independent techniques were performed. Similar microbiota expansion and alpha diversity were observed in MOM, RM10, and RM30 whether fresh or frozen milk was used as the inoculum. To evaluate if microbial expansion would result in an abnormal activation on the innate immune system, Caco-2 epithelial cells were exposed to RM/FRM to compare interleukin 8 levels with Caco-2 cells exposed to MOM or DHM. It was found that RM samples did not elicit a significant increase in IL-8 levels when compared to MOM or FMOM. These results suggest that FMOM can be used to inoculate DHM if fresh MOM is unavailable or limited in supply, allowing both fresh MOM and FMOM to be viable options in a microbial restoration strategy.
| S-EPMC8079756 | biostudies-literature
Project description:Human milk oligosaccharides (HMOs) are a major component of human milk, and play an important role in protecting the infant from infections. Preterm infants are particularly vulnerable, but have improved outcomes if fed with human milk. This study aimed to determine if the HMO composition of preterm milk differed from that of term milk at equivalent stage of lactation and equivalent postmenstrual age. In all, 22 HMOs were analyzed in 500 samples of milk from 25 mothers breastfeeding very preterm infants (< 32 weeks of gestational age, < 1500g of birthweight) and 28 mothers breastfeeding term infants. The concentrations of most HMOs were comparable at equivalent postpartum age. However, HMOs containing α-1,2-linked fucose were reduced in concentration in preterm milk during the first month of lactation. The concentrations of a number of sialylated oligosaccharides were also different in preterm milk, in particular 3'-sialyllactose concentrations were elevated. At equivalent postmenstrual age, the concentrations of a number of HMOs were significantly different in preterm compared to term milk. The largest differences manifest around 40 weeks of postmenstrual age, when the milk of term infants contains the highest concentrations of HMOs. The observed differences warrant further investigation in view of their potential clinical impact.
| S-EPMC6627155 | biostudies-literature