title: Use of cholecystokinin-octapeptide for the prevention of parenteral nutrition-associated cholestasis.
abstract: OBJECTIVE
  To determine whether cholecystokinin-octapeptide (CCK-OP) would prevent or ameliorate parenteral nutrition-associated cholestasis (PNAC) among high-risk neonates treated with total parenteral nutrition.
  
  
  METHODS
  This was a multicenter, double-blind, randomized, controlled trial conducted between 1996 and 2001.
  
  
  METHODS
  Neonates at risk for the development of PNAC included very low birth weight neonates and those with major surgical conditions involving the gastrointestinal tract.
  
  
  METHODS
  Tertiary care hospitals.
  
  
  METHODS
  Patients were randomized to receive CCK-OP (0.04 mug/kg per dose, twice daily) or placebo. Eligible infants were all <30 days of age. Patients were enrolled within 2 weeks after birth or within 7 days after surgery.
  
  
  METHODS
  The primary outcome measure was conjugated bilirubin (CB) levels, which were measured weekly. Secondary outcome measures included incidence of sepsis, times to achieve 50% and 100% of energy intake through the enteral route, number of ICU and hospital days, mortality rate, and incidences of biliary sludge and cholelithiasis.
  
  
  RESULTS
  A total of 243 neonates were enrolled in the study. CCK-OP administration did not significantly affect CB levels (1.76 +/- 3.14 and 1.93 +/- 3.31 mg/dL for CCK-OP and placebo groups, respectively; mean +/- SD). Secondary outcome measures also were not significantly affected by the study drug.
  
  
  CONCLUSIONS
  Use of CCK-OP failed to reduce significantly the incidence of PNAC or levels of CB. CCK-OP had no effect on other secondary measures and should not be recommended for the prevention of PNAC.
authors.affiliation: Department of Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan 48109-0245, USA. dttlbm@umich.edu
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Teitelbaum
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Tracy
authors.forename: Moustafa M
authors.initials: MM
authors.lastname: Aouthmany
authors.forename: Adolfo
authors.initials: A
authors.lastname: Llanos
authors.forename: Morton B
authors.initials: MB
authors.lastname: Brown
authors.forename: Sunkyung
authors.initials: S
authors.lastname: Yu
authors.forename: Marilyn R
authors.initials: MR
authors.lastname: Brown
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Shulman
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Hirschl
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Derusso
authors.forename: Jeanne
authors.initials: J
authors.lastname: Cox
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Dahlgren
authors.forename: Jonathan I
authors.initials: JI
authors.lastname: Groner
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Strouse
mesh_terms: D001663:Bilirubin / Q000097:blood; D002779:Cholestasis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005704:Gallbladder / Q000000981:diagnostic imaging; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000209:etiology / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D010289:Parenteral Nutrition, Total / Q000009:adverse effects*; D012844:Sincalide / Q000627:therapeutic use*; D017211:Treatment Failure; D014463:Ultrasonography
chemical_list: D012844:Sincalide; D001663:Bilirubin