Clinical trial NCT02692326: Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
Official title: DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholestasis in Newborn
Keywords: intrahepatic cholestasis
infant newborn
cyclic parenteral nutrition
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: % patients with parenteral nutrition associated cholestasis (PNAC)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of sepsis
timeFrame: through study completion, an average of 1 year
measure: Incidence of catheter related sepsis (CRS)
timeFrame: through study completion, an average of 1 year
measure: Mean length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: Nutrition factors to the development of PNAC
timeFrame: through study completion, an average of 1 year
measure: Nutrition factors to the development of PNAC
timeFrame: through study completion, an average of 1 year
measure: Anticholestatic drugs
timeFrame: through study completion, an average of 1 year
measure: Anticholestatic drugs
timeFrame: through study completion, an average of 1 year
measure: Adverse effects of the method of cycling used
timeFrame: through study completion, an average of 1 year
measure: Mortality
timeFrame: through study completion, an average of 1 year
measure: Mortality
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Nelia Navarro patiño
Study officials:
References:
citation: Angelico M, Della Guardia P. Review article: hepatobiliary complications associated with total parenteral nutrition. Aliment Pharmacol Ther. 2000 May;14 Suppl 2:54-7. doi: 10.1046/j.1365-2036.2000.014s2054.x.