Cholestasis in Newborn
Conditions
Keywords
intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition
Brief summary
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.
Interventions
PROCEDURECyclic parenteral nutrition
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.
Sponsors
Hospital General Universitario Gregorio Marañon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Days to 50 Days
Healthy volunteers
No
Inclusion criteria
* Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % patients with parenteral nutrition associated cholestasis (PNAC) | through study completion, an average of 1 year | The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter related sepsis (CRS) | through study completion, an average of 1 year | The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
| Mean length of hospital stay | through study completion, an average of 1 year | The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
| Nutrition factors to the development of PNAC | through study completion, an average of 1 year | total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
| Incidence of sepsis | through study completion, an average of 1 year | The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
| Adverse effects of the method of cycling used | through study completion, an average of 1 year | Percentage of adverse effects, type of adverse affects |
| Mortality | through study completion, an average of 1 year | the percentage of patients who died and the cause of death |
| Anticholestatic drugs | through study completion, an average of 1 year | % of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN. |
Countries
Spain
Outcome results
None listed