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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: Active Phase 2 study of Bilirubin Encephalopathy, sponsored by The University of Texas Health Science Center, Houston.

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, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 134 participants
Start Date 2021-02-11
Est. Completion 2026-06-14
Phase Phase 2

What the registry record for NCT04584983 still lists

NCT04584983 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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 a single indexed study location in 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.

How this trial's enrollment target compares

Where NCT04584983's enrollment target sits among peer trials

134 537th of 2000 higher than 1,463 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT04584983, the US trial registry maintained by the National Library of Medicine. NCT04584983 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.