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Full parenteral nutrition light protection of the bag, tubing and lipids for Premature Birth
N/A
Waitlist Available
Led By Caterina Tiozza, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 3, 5, and every 7 days after tpn initiation until 2 weeks after the end of iv nutrition
Awards & highlights
Study Summary
This study is evaluating whether full light protection of the PN can prevent cholestasis and other oxidative stress associated diseases in premature infants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0, 3, 5, and every 7 days after tpn initiation until 2 weeks after the end of iv nutrition
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 3, 5, and every 7 days after tpn initiation until 2 weeks after the end of iv nutrition
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serum levels of carnitine
Serum levels of direct bilirubin
Serum levels of liver enzymes
+2 moreSecondary outcome measures
Incidence of bronchopulmonary disease (BPD)
Incidence of necrotizing enterocolitis (NEC)
Incidence of retinopathy of prematurity (ROP)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Premature infantsExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,562 Total Patients Enrolled
6 Trials studying Premature Birth
79 Patients Enrolled for Premature Birth
Caterina Tiozza, MDPrincipal InvestigatorNYU Langone Health
Frequently Asked Questions
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