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NCT04525872 · ClinicalTrials.gov registry record · NA
Parenteral Nutrition Light Protection and Premature Outcomes
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT04525872: Completed NA study, sponsored by NYU Langone Health.
NCT04525872 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04525872, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline
Interventions
- OTHER Full parenteral nutrition light protection of the bag, tubing and lipids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2022-07-26 |
| Phase | NA |
What the finished NCT04525872 record still lists
NCT04525872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Full parenteral nutrition light protection of the bag, tubing and lipids is the first listed.
NCT04525872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04525872 about?
NCT04525872 is a clinical study titled "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 protect...
What is the current status of trial NCT04525872?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2020-07-10. Estimated completion is 2022-07-26.
What interventions are being tested in trial NCT04525872?
The interventions under investigation include: Full parenteral nutrition light protection of the bag, tubing and lipids (OTHER).
Who is sponsoring clinical trial NCT04525872?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04525872's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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