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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies \< 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia.
Nelia Navarro patiño
Madrid, Madrid, Spain
% patients with parenteral nutrition associated cholestasis (PNAC)
The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Incidence of sepsis
The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Incidence of catheter related sepsis (CRS)
The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Mean length of hospital stay
The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Nutrition factors to the development of PNAC
total days on parenteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Anticholestatic drugs
% of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Anticholestatic drugs
days of duration of treatment with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time frame: through study completion, an average of 1 year
Adverse effects of the method of cycling used
Percentage of adverse effects, type of adverse affects
Time frame: through study completion, an average of 1 year
Mortality
the percentage of patients who died and the cause of death
Time frame: through study completion, an average of 1 year
Mortality
The cause of death
Time frame: through study completion, an average of 1 year
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