Use of cholecystokinin-octapeptide for the prevention of parenteral nutrition-associated cholestasis.
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.
Teitelbaum
Daniel H
DH
Department of Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan 48109-0245, USA. dttlbm@umich.edu
Tracy
Thomas F
TF
Aouthmany
Moustafa M
MM
Llanos
Adolfo
A
Brown
Morton B
MB
Yu
Sunkyung
S
Brown
Marilyn R
MR
Shulman
Robert J
RJ
Hirschl
Ronald B
RB
Derusso
Patricia A
PA
Cox
Jeanne
J
Dahlgren
Jacqueline
J
Groner
Jonathan I
JI
Strouse
Peter J
PJ
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
D012844:Sincalide; D001663:Bilirubin