Back to resultsParenteral Nutrition Light Protection and Premature Outcomes
Primary Purpose
Premature Birth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full parenteral nutrition light protection of the bag, tubing and lipids
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Birth
Eligibility 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Premature infants
Arm 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
Outcomes
Primary Outcome Measures
Serum levels of direct bilirubin
Change from baseline
Serum levels of liver enzymes
Change from baseline
Serum levels of triglycerides
Change from baseline
Serum levels of carnitine
Change from baseline
Serum levels of total bilirubin
Change from baseline
Secondary Outcome Measures
Oxidative stress
Change from baseline
Incidence of bronchopulmonary disease (BPD)
Incidence of retinopathy of prematurity (ROP)
Incidence of necrotizing enterocolitis (NEC)
Mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04525872
Brief Title
Parenteral Nutrition Light Protection and Premature Outcomes
Official Title
Parenteral Nutrition Light Protection and Premature Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Premature infants
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Full parenteral nutrition light protection of the bag, tubing and lipids
Intervention Description
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
Primary Outcome Measure Information:
Title
Serum levels of direct bilirubin
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Title
Serum levels of liver enzymes
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Title
Serum levels of triglycerides
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Title
Serum levels of carnitine
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Title
Serum levels of total bilirubin
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Secondary Outcome Measure Information:
Title
Oxidative stress
Description
Change from baseline
Time Frame
Baseline, 2 weeks after the end of IV nutrition
Title
Incidence of bronchopulmonary disease (BPD)
Time Frame
Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Title
Incidence of retinopathy of prematurity (ROP)
Time Frame
Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Title
Incidence of necrotizing enterocolitis (NEC)
Time Frame
Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Title
Mortality
Time Frame
Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Tiozza, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Parenteral Nutrition Light Protection and Premature Outcomes
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