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NCT04584983 · ClinicalTrials.gov registry record · Phase 2
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
A Phase 2 study of Bilirubin Encephalopathy, sponsored by The University of Texas Health Science Center, Houston.
- Active
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT04584983 is a Phase 2 study of Bilirubin Encephalopathy that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 134 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04584983, a Phase 2 study of Bilirubin Encephalopathy, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
Conditions Studied
Interventions
- DRUG usual prescribed intralipid (UL) regimen
- DRUG restricted prescribed intralipid (RL) regimen
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2026-06-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04584983
The ClinicalTrials.gov registry entry for NCT04584983 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bilirubin Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which usual prescribed intralipid (UL) regimen is the first listed.
NCT04584983 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04584983 about?
NCT04584983 is a clinical study titled "Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration". The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
What is the current status of trial NCT04584983?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2021-02-11. Estimated completion is 2026-06-14.
What conditions does trial NCT04584983 study?
This clinical trial studies the following conditions: Bilirubin Encephalopathy.
What interventions are being tested in trial NCT04584983?
The interventions under investigation include: usual prescribed intralipid (UL) regimen (DRUG), restricted prescribed intralipid (RL) regimen (DRUG).
Who is sponsoring clinical trial NCT04584983?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04584983 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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