Cholestasis in Newborn Clinical Trial
Official title:
DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus
continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary
aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital
stay, mortality, nutritional status at two years of chronological age and predisposing
factors to the development of parenteral nutrition associated cholestasis (PNAC) between the
two groups, and to evaluate the adverse effects of the method of cycling used.
This was a single-center, prospective randomized not blinded study was conducted in a level
3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic
instability until a stable situation, congenital hepatic disease, preterm infants with
diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of
authorization from the parents or guardians were excluded.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06366880 -
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
|
N/A |