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NCT04621279 · ClinicalTrials.gov registry record
Cool Prime Comparative Effectiveness Study for Mild HIE
A clinical trial of Mild Hypoxic Ischemic Encephalopathy of Newborn, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 460
- Enrollment target
- 1
- Study location
NCT04621279: Recruiting study of Mild Hypoxic Ischemic Encephalopathy of Newborn, sponsored by University of Texas Southwestern Medical Center.
NCT04621279 is a study of Mild Hypoxic Ischemic Encephalopathy of Newborn that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 460 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04621279, a study of Mild Hypoxic Ischemic Encephalopathy of Newborn, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 460 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.
Primary Outcome
Effectiveness of normothermia in infants is measured by Composite Bayley IV score scale, which is. an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. Possible scores range from 55- 120 where lower scores indicate worse outcome.
Conditions Studied
Interventions
- PROCEDURE Normothermia
- PROCEDURE Whole body therapeutic hypothermia
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2023-07-19 |
| Est. Completion | 2029-01-01 |
What NCT04621279 shows while recruiting
NCT04621279 is an observational study that tracks outcomes without assigning an intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Mild Hypoxic Ischemic Encephalopathy of Newborn appearing as the primary indexed condition, and to 2 interventions - of which Normothermia is the first listed.
NCT04621279 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04621279 about?
NCT04621279 is a clinical study titled "Cool Prime Comparative Effectiveness Study for Mild HIE". To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the ...
What is the current status of trial NCT04621279?
This trial is currently recruiting. The enrollment target is 460 participants. The study started on 2023-07-19. Estimated completion is 2029-01-01.
What conditions does trial NCT04621279 study?
This clinical trial studies the following conditions: Mild Hypoxic Ischemic Encephalopathy of Newborn.
What interventions are being tested in trial NCT04621279?
The interventions under investigation include: Normothermia (PROCEDURE), Whole body therapeutic hypothermia (PROCEDURE).
Who is sponsoring clinical trial NCT04621279?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04621279 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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