Dataset Information

Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.

ABSTRACT: INTRODUCTION:Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk. PATIENTS AND METHODS:LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, placebo-controlled phase 3 study in infants born before 32 weeks of gestation. The primary efficacy variable was growth velocity (g/kg/day) during 4 weeks intervention. Follow-up visits were at 3 and 12 months. The study was performed at 54 centers in 10 European countries. RESULTS:In total 415 patients were randomized (rhBSSL n = 207, placebo n = 208), 410 patients were analyzed (rhBSSL n = 206, placebo n = 204) and 365 patients were followed until 12 months. Overall, there was no significantly improved growth velocity during rhBSSL treatment compared to placebo (16.77 vs. 16.56 g/kg/day, estimated difference 0.21 g/kg/day, 95% CI [-0.40; 0.83]), nor were secondary endpoints met. However, in a predefined subgroup, small for gestational age infants, there was a significant effect on growth in favor of rhBSSL during treatment. The incidence of adverse events was higher in the rhBSSL group during treatment. CONCLUSIONS:Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age, and there was an imbalance in short-term safety, these data provide insights in nutrition, growth and development in preterm infants. TRIAL REGISTRATION:ClinicalTrials.gov NCT01413581.

SUBMITTER: Casper C

PROVIDER: S-EPMC4887005 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.

Casper Charlotte C Hascoet Jean-Michel JM Ertl Tibor T Gadzinowski Janusz S JS Carnielli Virgilio V Rigo Jacques J Lapillonne Alexandre A Couce María L ML Vågerö Mårten M Palmgren Ingrid I Timdahl Kristina K Hernell Olle O

PloS one 20160531 5

<h4>Introduction</h4>Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk.<h4>Patients and methods</h4>LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, ...[more]

PMID: 27244221

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Project description:Breast milk contains bile salt-stimulated lipase (BSSL), which significantly increases the fat digestion capacity of newborns who have limited pancreatic lipase secretion in the first few months after birth. Problematically, Holder pasteurization used in non-profit milk banks to ensure the microbiological safety of donor milk for infants, particularly preterm infants (<37 weeks gestation age), destroys milk BSSL, thus limiting infant fat absorption capacity. Alternative strategies are needed to ensure the safety of donor milk while preserving BSSL activity. Three alternative pasteurization techniques-high-pressure processing (HPP, 550 MPa, 5 min), gamma cell irradiation (IR, 2.5 Mrads) and UV-C (254 nm, 0-33,000 J/L)-were compared with Holder pasteurization (low-temperature long-time, LTLT, 62.5°C, 30 min) for retention of BSSL activity in donor breast milk. As the time required for donor milk pasteurization by UV-C in published methods was not clear, donor breast milk was spiked with seven common bacterial strains and treated by UV-C for variable time periods and the minimum UV-C dosage required to achieve a 5-log10 reduction of CFU/mL was determined. Eight thousand two hundred fifty J/L of UV-C exposure was sufficient to achieve 5-log10 reduction of each of bacterial targets, including Bacillus and Paenibacillus spores. The retention of BSSL activity was highest after HPP (retaining 62% of the untreated milk BSSL activity), followed by UV-C (16,500 J/L), IR and LTLT (35, 29, and 0.3% retention, respectively). HPP was an effective alternative to pasteurize milk with improved retention of BSSL activity compared to Holder pasteurization. Future work should investigate the effect of alternative pasteurization techniques on the entire array of bioactive components in donor breast milk and how these changes affect preterm infant health outcomes. Implementation of HPP technique at milk banks could improve donor milk-fed infant fat absorption and growth.

Project description:BackgroundPreterm infants have difficulty maintaining engagement throughout early oral feedings, which can lead to less efficient feeding and prolonged feeding skill development.ObjectiveTo examine contributions of the infant, mother, and feeding context to infant engagement during bottle-feeding.MethodsBottle-feedings of very-low-birthweight infants (n = 22) by their mothers were observed. Infant and maternal behaviors were coded and synchronized with physiologic measures. At completion of the feeding, the mothers were interviewed, and their working model of feeding coregulation was scored. Feedings were subdivided into feeding episodes (n = 114). Using multilevel linear regression analyses, four dyadic characteristics (working model of the caregiver's role as coregulator, birthweight, postconceptional age, baseline oxygen saturation) and five episode characteristics (readiness at episode onset, episode baseline oxygen saturation, mean oxygen saturation during the episode, maternal feeding behavior, and phase of feeding) were examined as potential predictors of feeding episode engagement.ResultsConditions observed during the feeding observation explained most of the variation in engagement. Engagement was more likely to occur during the early phase of feeding (p <.05), during feeding episodes that began with infant readiness (p <.05), and during feeding episodes with higher mean oxygen saturation during the episode (p <.05). Feeding episodes with less jiggling of the nipple had a significantly greater amount of engagement (p <.05).ConclusionsThe ability of the preterm infant to maintain engagement during bottle-feeding cannot be explained by characteristics of the infant or by the prefeeding condition of the infant alone. Rather, engagement is coregulated by the caregiver and the infant throughout the feeding. Strategies to assist infants in maintaining physiologic stability during bottle-feeding and further study of effective and contingent caregiver feeding behaviors are needed.

Dataset Information

Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.

Publications

Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.

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