Gastric emptying in healthy newborns fed an intact protein formula, a partially and an extensively hydrolysed formula

Staelens, Sofie; Driessche, M. Van Den; Barclay, Denis; Carrié-Faessler, Anne-Lise; Haschke, Ferdinand; Verbeke, Kristin; Vandebroek, Hilde; Allegaert, Karel; Overmeire, Bart Van; Damme, Mieke Van; Veereman-Wauters, G.

doi:10.1016/j.clnu.2007.12.009

Cited by 58 publications

(47 citation statements)

References 22 publications

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“…For all previous simulations, variability ranges for CL, GET, and SITT were assigned to account for the interindividual variability. These values were either set by the software, as in software 1—CL: mean value ± 30% CV; GET: mean value ± 38% CV; SITT: Weibull distribution around the mean value with α = 2.92 and β = 4.04; or were assigned manually based on a comprehensive literature search as in software 2: lognormal distribution with geometric standard deviation of 1.3 for CL, GET: uniform distribution of 0.2–1.9 h in adults (49,50) and 0.2–2.1 h in children (51–54), and SITT: normal distribution with a mean value of 4 ± 1 h in both (49,55). …”

Section: Methodsmentioning

confidence: 99%

Physiologically Based Pharmacokinetic Models in the Prediction of Oral Drug Exposure Over the Entire Pediatric Age Range—Sotalol as a Model Drug

Khalil

Läer

2014

AAPS J

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In recent years, the increased interest in pediatric research has enforced the role of physiologically based pharmacokinetic (PBPK) models in pediatric drug development. However, an existing lack of published examples contributes to some uncertainties about the reliability of their predictions of oral drug exposure. Developing and validating pediatric PBPK models for oral drug application shall enrich our knowledge about their limitations and lead to a better use of the generated data. This study was conducted to investigate how whole-body PBPK models describe the oral pharmacokinetics of sotalol over the entire pediatric age. Two leading software tools for whole-body PBPK modeling: Simcyp® (Simcyp Ltd, Sheffield, UK) and PK-SIM® (Bayer Technology Services GmbH, Leverkusen, Germany), were used. Each PBPK model was first validated in adults before scaling to children. Model input parameters were collected from the literature and clinical data for 80 children were used to compare predicted and observed values. The results obtained by both models were comparable and gave an adequate description of sotalol pharmacokinetics in adults and in almost all pediatric age groups. Only in neonates, the mean ratio(Obs/Pred) for any PK parameter exceeded a twofold error range, 2.56 (95% confidence interval (CI), 2.10–3.49) and 2.15 (95% CI, 1.77–2.99) for area under the plasma concentration-time curve from the first to the last concentration point and maximal concentration (Cmax) using SIMCYP® and 2.37 (95% CI, 1.76–3.25) for time to reach Cmax using PK-SIM®. The two PBPK models evaluated in this study reflected properly the age-related pharmacokinetic changes and predicted adequately the oral sotalol exposure in children of different ages, except in neonates.

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Section: Methodsmentioning

confidence: 99%

Physiologically Based Pharmacokinetic Models in the Prediction of Oral Drug Exposure Over the Entire Pediatric Age Range—Sotalol as a Model Drug

Khalil

Läer

2014

AAPS J

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“…A doubleblind, randomized, crossover study compared gastric emptying in 20 healthy newborns fed CM-SF, pHF and eHF containing 50 ml 13 C-octanoic acid. eHF resulted in significantly faster gastric emptying than SF and pHF (medians 46 vs. 55 and 53 min, respectively) [45] .…”

Section: Treatment Of Allergymentioning

confidence: 86%

Hydrolyzed Proteins in Allergy

Salvatore

Vandenplas

2016

Nestlé Nutrition Institute Workshop Series

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Hydrolyzed proteins are used worldwide in the therapeutic management of infants with allergic manifestations and have long been proposed as a dietetic measure to prevent allergy in at risk infants. The degree and method of hydrolysis, protein source and non-nitrogen components characterize different hydrolyzed formulas (HFs) and may determine clinical efficacy, tolerance and nutritional effects. Cow's milk (CM)-based HFs are classified as extensively (eHF) or partially HF (pHF) based on the percentage of small peptides. One whey pHF has been shown to reduce atopic dermatitis in high-risk infants who are not exclusively breastfed. More studies are needed to determine the benefit of these formulas in the prevention of CM allergy (CMA) and in the general population. eHFs represent up to now the treatment of choice for most infants with CMA. However, new developments, such as an extensively hydrolyzed rice protein-based formula, could become alternative options if safety and nutritional and therapeutic efficacy are confirmed as this type of formula is less expensive. In some countries, an extensive soy hydrolysate is available.

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“…Use of hydrolysed, compared to intact protein, in formula-fed term [82] and preterm infants [83,84] has been shown to accelerate gastrointestinal transit time [83] and to accelerate feeding advancement [84]. The degree to which the protein is hydrolysed may moderate the rate of gastric emptying with increased rates demonstrated with use of extensively, rather than partially, hydrolysed formula [82]. It is unclear whether utilization of the hydrolysed protein is compromised by the tendency towards higher frequency of stools that appear to be generated through its use [83].…”

Section: Hydrolysed Vs Intact Proteinmentioning

confidence: 99%

Breast Milk Additives and Infant Formula

Sherriff

McLeod

2013

Nutrition for the Preterm Neonate

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Breast milk is recommended for very preterm infants but fortification is required to increase its nutrient density in order to promote growth and development. Even with fortification, those born extremely preterm and those who are fluid restricted may not achieve intrauterine growth targets. Thus, fortification beyond routine amounts may be necessary for some infants. Further study is necessary to determine optimal methods, types and amounts of fortification, as well as upper limits of osmolality, so as to ensure avoidance of feeding intolerance and necrotizing enterocolitis whilst achieving appropriate rate of weight gain and accretion of nutrients. The efficacy of new formulations of fortifiers and infant formulae needs further study. Key points• Breast milk requires fortification to meet the nutrient needs of preterm infants; monitoring protein intake via blood urea nitrogen to guide fortification looks promising.• Breast milk fortifiers have variable effects on osmolality of fortified expressed breast milk.• Randomised controlled trials are required to assess the efficacy of recently revised formulations of breast milk fortifier and preterm formulae in the context of their ability to meet nutritional requirements for growth and effect on osmolality and feeding intolerance.• Use of gum-based thickening agents for treatment of regurgitation is associated with increased risk of necrotising enterocolitis in preterm and term infants.

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Gastric emptying in healthy newborns fed an intact protein formula, a partially and an extensively hydrolysed formula

Cited by 58 publications

References 22 publications

Physiologically Based Pharmacokinetic Models in the Prediction of Oral Drug Exposure Over the Entire Pediatric Age Range—Sotalol as a Model Drug

Physiologically Based Pharmacokinetic Models in the Prediction of Oral Drug Exposure Over the Entire Pediatric Age Range—Sotalol as a Model Drug

Hydrolyzed Proteins in Allergy

Breast Milk Additives and Infant Formula

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