Investigators propose a prospective study to investigate the effect of full light protection of the PN on cholestasis and other oxidative stress associated diseases in premature infants when they receive PN for more than one week. Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing. Demographic characteristics, clinical outcomes (incidence of cholestasis, feeding tolerance, BPD, ROP, NEC and mortality) and oxidative stress markers (e.g., carboxyhemeglobin) will be evaluated. Phase one of this study employed a retrospective chart review methodology to evaluate the effect of no PN light protection vs partial PN light protection (PN solution only while it's the tubing and lipids remained exposed to light). Infants from phase one of this study will serve as the controls in the evaluation the effect of full PN light protection on the cholestasis, clinical outcomes and oxidative stress. Investigators propose to collect urine and saliva samples in infants who we expect to receive PN for a minimum of 5 days, on days 0, 3, 5 and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition to evaluate oxidative stress.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
NYU Langone Health
New York, New York, United States
Serum levels of direct bilirubin
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Serum levels of liver enzymes
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Serum levels of triglycerides
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Serum levels of carnitine
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Serum levels of total bilirubin
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Oxidative stress
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Incidence of bronchopulmonary disease (BPD)
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Incidence of retinopathy of prematurity (ROP)
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Incidence of necrotizing enterocolitis (NEC)
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Mortality
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
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