Parenteral Nutrition Light Protection and Premature Outcomes

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Other: Full parenteral nutrition light protection of the bag, tubing and lipids

• Registration Number: NCT04525872
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-25
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Premature infants	Full parenteral nutrition light protection of the bag, tubing and lipids	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

Primary Outcome Measures

Name	Time	Method
Serum levels of direct bilirubin	Baseline, 2 weeks after the end of IV nutrition	Change from baseline
Serum levels of liver enzymes	Baseline, 2 weeks after the end of IV nutrition	Change from baseline
Serum levels of triglycerides	Baseline, 2 weeks after the end of IV nutrition	Change from baseline
Serum levels of carnitine	Baseline, 2 weeks after the end of IV nutrition	Change from baseline
Serum levels of total bilirubin	Baseline, 2 weeks after the end of IV nutrition	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Mortality	Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Oxidative stress	Baseline, 2 weeks after the end of IV nutrition	Change from baseline
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States