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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 36 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04525872
The ClinicalTrials.gov registry entry for NCT04525872 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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