Parenteral Nutrition Light Protection and Premature Outcomes

NYU Langone Health

Status: Completed

Conditions: Premature Birth

Treatments: Other: Full parenteral nutrition light protection of the bag, tubing and lipids

Study type: Interventional

Funder types: Other

Identifiers

NCT04525872

20-00378

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Preterm infants <32 weeks of gestation, who receive TPN for a minimum of 5 days
• Infants with gastrointestinal surgical problems (e.g., ileal atresia, gastroschisis), expected to receive TPN for a minimum of 5 days Exclusion criteria
• Infants who receive TPN for <5 days
• Infants who developed cholestasis due to non-TPN-related causes

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Premature infants

Experimental group

Description:

Premature infants who are expected to receive TPN for a minimum of 5 days and infants with gastrointestinal surgical problems (e.g., ileal atresia, gastroschisis), expected to receive TPN for a minimum of 5 days

Treatment:

Other: Full parenteral nutrition light protection of the bag, tubing and lipids