Parenteral Nutrition Light Protection and Premature Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Other: Full parenteral nutrition light protection of the bag, tubing and lipids

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premature infants; 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; Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Caterina Tiozza, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 20-00378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: caterina.tiozzo@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to caterina.tiozzo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No