Dataset Information

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study.

ABSTRACT: Fortifying human milk contributes to the prevention of postnatal growth failure in preterm infants. Because of the natural variability of human milk, targeted fortification of human milk has been advocated. However, data regarding the efficacy and safety of prolonged targeted fortification are scarce. We aimed to assess the safety of targeted fortification of human milk in preterm infants compared with standard fortification, as well as the effects on infant growth.We conducted an interventional study during hospital stay in healthy very low birth weight preterm infants who were exclusively fed human milk. Pools of human milk collected for 24 h were analysed using mid-infrared transmission spectroscopy. Targeted fortification of human milk was performed by adding macronutrients to native human milk to obtain optimal ratios of fat (4.4 g), carbohydrates (8.8 g), and protein (3 g) per 100 ml. The intervention period lasted 4-7 weeks. Weekly weight and daily growth rates were compared with those of a standardized fortification group of very low birth weight preterm infants who received standard fortified human milk (n = 10). The osmolality as well as the metabolic and gastrointestinal tolerance were monitored. Intergroup differences were evaluated using the Mann-Whitney U-test.A total of 10 preterm infants (birth weight 1223 ± 195 g; gestational age 29.1 ± 1.03 weeks) were enrolled and 118 samples of pooled milk were analysed. On average, 1.4 ± 0.1 g of protein, 2.3 ± 0.5 g of carbohydrate, and 0.3 ± 0.1 g of fat per 100 ml were added to the milk. Osmolality values after target fortification were within recommended limits (376 ± 66 mOsml/kg). Weekly weight gain (205.5 g; 95 % CI 177-233 vs 155 g; 95 % CI 132-178; p = 0.025) and daily growth rates (15.7 g/kg/day; 95 % CI 14.5-16.9 vs 12.3 g/kg/day; 95 % CI 10.7-13.9; p = 0.005) were higher in infants receiving target fortification than in infants receiving standardized fortification. The infants receiving targeted fortified milk consumed similar volumes as infants in the standardized fortification group (148 ± 4.5 vs 146 ± 4 ml/kg/day). No signs of either gastrointestinal or metabolic intolerance were observed.Target fortification appears to promote growth in very low birth weight preterm infants without any detrimental effects. Trial registration NCT02716337.

SUBMITTER: Morlacchi L

PROVIDER: S-EPMC4930619 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study.

Morlacchi Laura L Mallardi Domenica D Giannì Maria Lorella ML Roggero Paola P Amato Orsola O Piemontese Pasqua P Consonni Dario D Mosca Fabio F

Journal of translational medicine 20160701 1

<h4>Background</h4>Fortifying human milk contributes to the prevention of postnatal growth failure in preterm infants. Because of the natural variability of human milk, targeted fortification of human milk has been advocated. However, data regarding the efficacy and safety of prolonged targeted fortification are scarce. We aimed to assess the safety of targeted fortification of human milk in preterm infants compared with standard fortification, as well as the effects on infant growth.<h4>Methods ...[more]

PMID: 27370649

Similar Datasets

Project description:BackgroundMortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We aimed to investigate whether supplementation with human milk-based fortifier (HMBF), as compared to bovine milk-based fortifier (BMBF), reduced the incidence of the composite outcome of necrotising enterocolitis (NEC), sepsis, and mortality in extremely preterm infants exclusively fed human milk.MethodsIn this multicentre, randomised controlled trial at 24 neonatal units in Sweden, extremely preterm infants born between gestational week 22 + 0 and 27 + 6 fed exclusively human breast milk (mother's own and/or donor milk), were randomly assigned (1:1) to receive targeted fortification with either HMBF or BMBF. Randomisation was conducted before the enteral feeds reached 100 mL/kg/day, and was stratified by enrolment site, gestational age, singleton/twin, and sex. The allocation was concealed before inclusion, but after randomisation the study was not blinded for the clinical staff. For the NEC diagnosis, the study group was masked to an independent radiologist, and the final assessment of NEC and culture-proven sepsis was done by a blinded consensus panel review. The primary outcome was the composite of NEC stage II-III, culture-proven sepsis, and mortality from inclusion to discharge, no longer than postmenstrual week 44 + 0, in the intention-to-treat population (ClinicalTrials.gov, NCT03797157).FindingsBetween February 21st, 2019, and May 21st, 2021, 229 neonates were randomly assigned (115 HMBF, 114 BMBF). After exclusion of one infant due to parents' withdrawal of consent, 228 infants were included in the intention-to-treat analysis. Of the 115 infants assigned to HMBF, 41 (35.7%) fulfilled the criteria of either NEC, sepsis, or death, compared with 39 (34.5%) of 113 infants assigned to BMBF (OR 1.05, 95% CI 0.61-1.81, p = 0.86). Adverse events did not differ significantly between groups.InterpretationSupplementation with HMBF, as compared with BMBF, did not reduce the incidence of the composite outcome of NEC, sepsis, or death. Our results do not support routine supplementation with HMBF as a nutritional strategy to prevent NEC, sepsis, or death in extremely preterm infants exclusively fed human milk.FundingALF grant, Prolacta Bioscience, Swedish Research Council, and Research Council for Southeast Sweden.

Project description:BackgroundPreterm birth is associated with an increased risk of many complications, which is a main public health problem worldwide with social and economic consequences. Human milk from breast feeding has been proved to be the optimal nutrition strategy for preterm infants when available. However, the lack of human milk from mothers makes formula widely used in clinical practice. In recent years, donated breast milk has gained popularity as an alternative choice which can provide human milk oligosaccharides and other bioactive substances.ObjectiveWe aimed to conduct a systematic review and meta-analysis to evaluate the nutritional effects of donated breast milk on preterm infants compared with formula.MethodIn the present study, we searched Medline, Web of Science, Embase, clinicaltrials.gov, the China national knowledge infrastructure, and the Cochrane central register of controlled trials for candidate randomized controlled trials (RCTs).ResultsA total of 1390 patients were enrolled in 11 RCTs and meta-analysis results showed that donated breast milk is also more advantageous in reducing the incidence of necrotizing enterocolitis (NEC, RR = 0.67, 95% CI = 0.48 to 0.93, p = 0.02), reducing the duration of parenteral nutrition (MD = -2.39, 95% CI = -3.66 to -1.13, p = 0.0002) and the time of full enteral feeding (MD = -0.33, 95% CI = -3.23 to 2.57, p = 0.0002). In comparison, formula significantly promotes the growth of premature infants, including their weight gain (MD = -3.45, 95% CI = -3.68 to -3.21, p < 0.00001), head growth (MD = -0.07, 95% CI = -0.08 to -0.06, p < 0.00001) and body length (MD = -0.13, 95% CI = -0.15 to -0.11, p < 0.00001), and reduces the time it takes for premature infants to regain birth weight (MD = 6.60, 95% CI = 6.11 to 7.08, p < 0.00001.ConclusionCompared with formula, donated breast milk could significantly reduce the incidence of NEC, the duration of parenteral nutrition, and the time of full enteral feeding. Adding fortifiers in donated milk could make it as effective as formula in promoting the physical growth of premature infants.

Project description:IntroductionThe mortality rate of extremely low gestational age (ELGA) (born <gestational week 28+0) infants remains high, and severe infections and necrotising enterocolitis (NEC) are common causes of death. Preterm infants receiving human milk have lower incidence of sepsis and NEC than those fed a bovine milk-based preterm formula. Despite this, fully human milk fed ELGA infants most often have a significant intake of cow's milk protein from bovine-based protein fortifier. The aim of this study is to evaluate whether the supplementation of human milk-based, as compared with bovine-based, nutrient fortifier reduces the prevalence of NEC, sepsis and mortality in ELGA infants exclusively fed with human milk.Methods and analysisA randomised-controlled multicentre trial comparing the effect of a human breast milk-based fortifier with a standard bovine protein-based fortifier in 222-322 ELGA infants fed human breast milk (mother's own milk and/or donor milk). The infants will be randomised to either fortifier before reaching 100 mL/kg/day in oral feeds. The intervention, stratified by centre, will continue until the target postmenstrual week 34+0. The primary outcome is a composite of NEC, sepsis or death. Infants are characterised with comprehensive clinical and nutritional data collected prospectively from birth until hospital discharge. Stool, urine, blood and breast milk samples are collected for analyses in order to study underlying mechanisms. A follow-up focusing on neurological development and growth will be performed at 2 and 5.5 years of age. Health economic analyses will be made.Ethics and disseminationThe study is conducted according to ICH/GCP guidelines and is approved by the regional ethical review board in Linköping Sweden (Dnr 2018/193-31, Dnr 2018/384-32). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberThe study was registered with ClinicalTrials.gov NCT03797157, 9 January 2019.

Dataset Information

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study.

Publications

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets