Parenteral Nutrition Light Protection and Premature Outcomes
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2020
CompletedFirst Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2022
CompletedNovember 1, 2022
October 1, 2022
2 years
July 24, 2020
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (5)
Oxidative stress
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
Study Arms (1)
Premature infants
EXPERIMENTALPremature 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
Interventions
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
Eligibility Criteria
You may qualify if:
- Preterm infants \<32 weeks of gestation, who receive TPN for a minimum of 5 days
You may not qualify if:
- Infants who receive TPN for \<5 days
- Infants who developed cholestasis due to non-TPN-related causes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caterina Tiozza, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
August 25, 2020
Study Start
July 10, 2020
Primary Completion
July 15, 2022
Study Completion
July 26, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- Requests should be directed to caterina.tiozzo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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.