NCT04525872

Parenteral Nutrition Light Protection and Premature Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
OTHER	Full parenteral nutrition light protection of the bag, tubing and lipids	Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.

Timeline

• Start date: 2020-07-10
• Primary completion: 2022-07-15
• Completion: 2022-07-26
• First posted: 2020-08-25
• Last updated: 2022-11-01

Locations

1 site across 1 country: United States