Parenteral Nutrition Light Protection and Premature Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Parenteral Nutrition Light Protection and Premature Outcomes

Conditions
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Premature Birth

Intervention / Treatment
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* Other: Full parenteral nutrition light protection of the bag, tubing and lipids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premature infants<br>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 | Other: Full parenteral nutrition light protection of the bag, tubing and lipids<br>* Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of direct bilirubin | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 
| Serum levels of liver enzymes | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 
| Serum levels of triglycerides | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 
| Serum levels of carnitine | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 
| Serum levels of total bilirubin | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Change from baseline | Baseline, 2 weeks after the end of IV nutrition | 
| Incidence of bronchopulmonary disease (BPD) |  | 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) |  | 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) |  | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition | 
| Mortality |  | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition |