title: rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk.
abstract: OBJECTIVE
  Preterm infants often experience suboptimal growth, which can affect organ development. The aim of this study was to improve growth by treatment with bile salt-stimulated lipase (BSSL), naturally present in breast milk, but lost after pasteurization, and absent in formula.
  
  
  METHODS
  Two clinical trials were performed with a predefined analysis of combined data to investigate the effects of recombinant human BSSL (rhBSSL) treatment on growth velocity and fat absorption in preterm infants. The studies were randomized and double-blinded comparing 7-day treatment with rhBSSL and placebo, administered in pasteurized breast milk or formula, using a crossover design.
  
  
  RESULTS
  Sixty-three infants were evaluated for safety. At randomization, the mean (standard deviation) weight was 1467 (193) g and mean postmenstrual age was 32.6 (0.5) weeks. Sixty and 46 infants were evaluated for growth velocity and fat absorption, respectively. rhBSSL treatment significantly improved mean growth velocity by 2.93 g · kg · day (P<0.001) compared with placebo (mean 16.86 vs 13.93 g · kg · day) and significantly decreased the risk of suboptimal growth (<15 g · kg · day) (30% vs 52%, P=0.004). rhBSSL significantly increased absorption of the long-chain polyunsaturated fatty acids, docosahexaenoic acid, and arachidonic acid by 5.76% (P=0.013) and 8.55% (P=0.001), respectively, but had no significant effect on total fat absorption. The adverse-event profile was similar to placebo.
  
  
  CONCLUSIONS
  In preterm infants fed pasteurized breast milk or formula, 1 week of treatment with rhBSSL was well tolerated and significantly improved growth and long-chain polyunsaturated fatty acid absorption compared to placebo. This publication presents the first data regarding the use of rhBSSL in preterms and the results have led to further clinical studies.
authors.affiliation: *Unit of Neonatology, Children's Hospital, Paul Sabatier University Toulouse, Toulouse, France †Division of Neonatology, Polytechnic University of Marche and Salesi's Children Hospital, Ancona, Italy ‡Department of Neonatology, Maternite Regionale, Université de Lorraine, Nancy §Department of Neonatology, Assistance Publique Hôpitaux de Paris Necker Hospital, Paris Descartes University, Paris, France ||Division of Neonatology, Department of Pediatrics, Catholic University Sacred Heart, Rome, Italy ¶Swedish Orphan Biovitrum (Sobi), Stockholm #Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Casper
authors.forename: Virgilio P
authors.initials: VP
authors.lastname: Carnielli
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Hascoet
authors.forename: Alexandre
authors.initials: A
authors.lastname: Lapillonne
authors.forename: Luca
authors.initials: L
authors.lastname: Maggio
authors.forename: Kristina
authors.initials: K
authors.lastname: Timdahl
authors.forename: Birgitta
authors.initials: B
authors.lastname: Olsson
authors.forename: Mårten
authors.initials: M
authors.lastname: Vågerö
authors.forename: Olle
authors.initials: O
authors.lastname: Hernell
mesh_terms: D016718:Arachidonic Acid / Q000493:pharmacokinetics; D002657:Child Development; D018592:Cross-Over Studies; D004281:Docosahexaenoic Acids / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage; D007231:Infant, Newborn; D007234:Infant, Premature / Q000254:growth & development*; D019102:Infant, Very Low Birth Weight / Q000254:growth & development*; D007408:Intestinal Absorption / Q000187:drug effects*; D008297:Male; D008895:Milk, Human / Q000201:enzymology; D061352:Pasteurization; D011994:Recombinant Proteins / Q000627:therapeutic use; D002787:Sterol Esterase / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011994:Recombinant Proteins; D004281:Docosahexaenoic Acids; D016718:Arachidonic Acid; C054784:bile salt-stimulated lipase; D002787:Sterol Esterase