Recombinant bile salt-stimulated lipase in preterm infant feeding: A randomized phase 3 study

PLoS ONE

Volumn 11, Issue 5, 2016, Pages

  Casper, Charlotte ^a   Hascoet, Jean Michel ^b   Ertl, Tibor ^c   Gadzinowski, Janusz S ^d   Carnielli, Virgilio ^e   Rigo, Jacques ^f   Lapillonne, Alexandre ^g   Couce, María L ^h   Vågerö, Mårten ⁱ   Palmgren, Ingrid ⁱ   Timdahl, Kristina ⁱ   Hernell, Olle ^j  

^a UNIVERSITÉ PAUL SABATIER   (France)

^b UNIVERSITÉ DE LORRAINE   (France)

^c UNIVERSITY OF PÉCS   (Hungary)

^d POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^e UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^f UNIVERSITY OF LIÈGE   (Belgium)

^g HÔPITAL NECKER ENFANTS MALADES   (France)

^h University Hospital of Santiago de Compostela   (Spain)

ⁱ BIOVITRUM AB   (Sweden)

^j UMEÅ UNIVERSITY   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BILE SALT STIMULATED LIPASE; RECOMBINANT ENZYME; UNCLASSIFIED DRUG; BILE SALT-STIMULATED LIPASE; CHOLESTEROL ESTERASE; PLACEBO; RECOMBINANT PROTEIN;

ARTICLE; ARTIFICIAL MILK; BREAST FEEDING; BREAST MILK; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ENTERIC FEEDING; FEMALE; FOLLOW UP; GESTATIONAL AGE; GROWTH RATE; HUMAN; INFANT; INFANT FEEDING; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PREMATURITY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SMALL FOR DATE INFANT; ADVERSE EFFECTS; BOTTLE FEEDING; CHEMISTRY; CLINICAL TRIAL; DIETARY SUPPLEMENT; DRUG EFFECTS; GENETICS; GROWTH, DEVELOPMENT AND AGING; NEWBORN; PASTEURIZATION; PROCEDURES; WEIGHT GAIN;

BOTTLE FEEDING; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; ENTERAL NUTRITION; FEMALE; GESTATIONAL AGE; HUMANS; INFANT; INFANT FORMULA; INFANT, NEWBORN; INFANT, PREMATURE; MALE; MILK, HUMAN; PASTEURIZATION; PLACEBOS; RECOMBINANT PROTEINS; STEROL ESTERASE; WEIGHT GAIN;

EID: 84971596930     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0156071     Document Type: Article

References (28)

1. Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006; 117(4):1253-61. doi: 10.1542/peds.2005-1368 PMID: 16585322.
2. Lapillonne A, O'Connor DL, Wang D, Rigo J. Nutritional recommendations for the late-preterm infant and the preterm infant after hospital discharge. The Journal of pediatrics. 2013; 162(3 Suppl):S90-100. doi: 10.1016/j.jpeds.2012.11.058 PMID: 23445854.
3. Pilling EL, Elder CJ, Gibson AT. Growth patterns in the growth-retarded premature infant. Best practice & research Clinical endocrinology & metabolism. 2008; 22(3):447-62. doi: 10.1016/j.beem.2008.03.002 PMID: 18538285.
4. Clark RH, Thomas P, Peabody J. Extrauterine growth restriction remains a serious problem in prematurely born neonates. Pediatrics. 2003; 111(5 Pt 1):986-90. PMID: 12728076.
5. Miller J, Makrides M, Gibson RA, McPhee AJ, Stanford TE, Morris S, et al. Effect of increasing protein content of human milk fortifier on growth in preterm infants born at <31 wk gestation: a randomized controlled trial. The American journal of clinical nutrition. 2012; 95(3):648-55. doi: 10.3945/ajcn.111.026351 PMID: 22301933.
6. Lindquist S, Hernell O. Lipid digestion and absorption in early life: an update. Current opinion in clinical nutrition and metabolic care. 2010; 13(3):314-20. doi: 10.1097/MCO.0b013e328337bbf0 PMID: 20179589.
7. Bjorksten B, Burman LG, De Chateau P, Fredrikzon B, Gothefors L, Hernell O. Collecting and banking human milk: to heat or not to heat? British medical journal. 1980; 281(6243):765-9. PMID: 7427442; PubMed Central PMCID: PMC1714023.
8. Henderson TR, Fay TN, Hamosh M. Effect of pasteurization on long chain polyunsaturated fatty acid levels and enzyme activities of human milk. The Journal of pediatrics. 1998; 132(5):876-8. PMID: 9602205.
9. Hernell O. Human milk lipases. III. Physiological implications of the bile salt-stimulated lipase. European journal of clinical investigation. 1975; 5(3):267-72. PMID: 1149784.
10. Andersson Y, Savman K, Blackberg L, Hernell O. Pasteurization of mother's own milk reduces fat absorption and growth in preterm infants. Acta paediatrica. 2007; 96(10):1445-9. doi: 10.1111/j.1651-2227.2007.00450.x PMID: 17714541.
11. Andersson EL, Hernell O, Blackberg L, Falt H, Lindquist S. BSSL and PLRP2: key enzymes for lipid digestion in the newborn examined using the Caco-2 cell line. Journal of lipid research. 2011; 52(11):1949-56. doi: 10.1194/jlr.M015685 PMID: 21865348; PubMed Central PMCID: PMC3196226.
12. Li X, Lindquist S, Lowe M, Noppa L, Hernell O. Bile salt-stimulated lipase and pancreatic lipase-related protein 2 are the dominating lipases in neonatal fat digestion in mice and rats. Pediatric research. 2007; 62(5):537-41. doi: 10.1203/PDR.0b013e3181559e75 PMID: 17805199; PubMed Central PMCID: PMC3488855.
13. Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, et al. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. Journal of pediatric gastroenterology and nutrition. 2014; 59(1):61-9. doi: 10.1097/MPG.0000000000000365 PMID: 25222806; PubMed Central PMCID: PMC4086776.
14. Chen Q, Blackberg L, Nilsson A, Sternby B, Hernell O. Digestion of triacylglycerols containing long-chain polyenoic fatty acids in vitro by colipase-dependent pancreatic lipase and human milk bile salt-stimulated lipase. Biochimica et biophysica acta. 1994; 1210(2):239-43. PMID: 8280776.
15. Olsen IE, Groveman SA, Lawson ML, Clark RH, Zemel BS. New intrauterine growth curves based on United States data. Pediatrics. 2010; 125(2):e214-24. doi: 10.1542/peds.2009-0913 PMID: 20100760.
16. European Pharmacopoeia version 7.0:2661-63.
17. Shirai K, Jackson RL. Lipoprotein lipase-catalyzed hydrolysis of p-nitrophenyl butyrate. Interfacial activation by phospholipid vesicles. The Journal of biological chemistry. 1982; 257(3):1253-8. PMID: 6895751.
18. Bayley N. Bayley Scales of Infant and Toddler Development-Third Edition. San Antonio, TX: Harcourt Assessment Journal of psychoeducational assessment. 2006; 25(2):180-90. doi: 10.1177/0734282906297199
19. Funkquist EL, Tuvemo T, Jonsson B, Serenius F, Nyqvist KH. Milk for small infants. Acta paediatrica. 2007; 96(4):596-9. doi: 10.1111/j.1651-2227.2007.00222.x PMID: 17391476.
20. Barone G, Maggio L, Saracino A, Perri A, Romagnoli C, Zecca E. How to feed small for gestational age newborns. Italian journal of pediatrics. 2013; 39:28. doi: 10.1186/1824-7288-39-28 PMID: 23663313; PubMed Central PMCID: PMC3660241.
21. Makrides M, Gibson RA, McPhee AJ, Collins CT, Davis PG, Doyle LW, et al. Neurodevelopmental outcomes of preterm infants fed high-dose docosahexaenoic acid: a randomized controlled trial. Jama. 2009; 301(2):175-82. doi: 10.1001/jama.2008.945 PMID: 19141765.
22. Llanos A, Lin Y, Mena P, Salem N Jr., Uauy R. Infants with intrauterine growth restriction have impaired formation of docosahexaenoic acid in early neonatal life: a stable isotope study. Pediatric research. 2005; 58(4):735-40. doi: 10.1203/01.PDR.0000180542.68526.A2 PMID: 16189202.
23. Uauy R, Mena P, Wegher B, Nieto S, Salem N Jr. Long chain polyunsaturated fatty acid formation in neonates: effect of gestational age and intrauterine growth. Pediatric research. 2000; 47(1):127-35. PMID: 10625093.
24. Yang Y, Sanchez D, Figarella C, Lowe ME. Discoordinate expression of pancreatic lipase and two related proteins in the human fetal pancreas. Pediatric research. 2000; 47(2):184-8. PMID: 10674344.
25. Sharma R, Hudak ML. A clinical perspective of necrotizing enterocolitis: past, present, and future. Clinics in perinatology. 2013; 40(1):27-51. doi: 10.1016/j.clp.2012.12.012 PMID: 23415262; PubMed Central PMCID: PMC3575605.
26. Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeeding medicine: the official journal of the Academy of Breastfeeding Medicine. 2012; 7(5):323-4. doi: 10.1089/bfm.2012.0067 PMID: 22946888.
27. McLeod G, Sherriff J, Nathan E, Hartmann PE, Simmer K. Four-week nutritional audit of preterm infants born <33 weeks gestation. Journal of paediatrics and child health. 2013; 49(4):E332-9. doi: 10.1111/jpc.12013 PMID: 23227876.
28. Hascoet JMS, S.; Marchal, L.; Chauvin, M.; Pierret, C.; Franck P. Impact of maternal nutrition and perinatal factors on breast milk composition after premature delivery. E-PAS 2015:2902426.