NYU Langone Health
New York, 10016, United States
NCT Number: NCT04525872
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.
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Notify MeUp to 32 week
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
NYU Langone Health
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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