Who is sponsoring NCT04621279?

NCT04621279 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT04621279?

Interventions in NCT04621279: Normothermia, Whole body therapeutic hypothermia.

What condition does NCT04621279 study?

NCT04621279 studies Mild Hypoxic Ischemic Encephalopathy of Newborn.

Is NCT04621279 still recruiting?

NCT04621279 is currently recruiting now. Last updated 8 December 2025.

Last reviewed 2025-12-08 · How we verify

NCT04621279: COOLPRIME

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cool Prime Comparative Effectiveness Study for Mild HIE

Recruiting now Last updated 8 December 2025

What this trial tests

trial testing Normothermia in Mild Hypoxic Ischemic Encephalopathy of Newborn in 460 participants. Currently enrolling.

Timeline

19 July 2023

Primary endpoint
31 October 2026

1 January 2029

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	460
Start date	19 July 2023
Primary completion	31 October 2026
Estimated completion	1 January 2029
Sites	1 location across United States

Drugs / interventions tested

Normothermia
Whole body therapeutic hypothermia

Conditions studied

Mild Hypoxic Ischemic Encephalopathy of Newborn — all drugs for Mild Hypoxic Ischemic Encephalopathy of Newborn →

Sponsor

University of Texas Southwestern Medical Center

Who can join

36 Weeks and older, any sex, with Mild Hypoxic Ischemic Encephalopathy of Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cerebral Oxygenation and Metabolism After Hypoxia-Ischemia.
Dhillon SK, Gunn ER, Lear BA, King VJ, et al · · 2022 · cited 18× · PMID 35903161 · DOI 10.3389/fped.2022.925951
EEG Spectral Power: A Proposed Physiological Biomarker to Classify the Hypoxic-Ischemic Encephalopathy Severity in Real Time.
Kota S, Jasti K, Liu Y, Liu H, et al · · 2021 · cited 15× · PMID 34243047 · DOI 10.1016/j.pediatrneurol.2021.06.001
Prognostic value of quantitative EEG in early hours of life for neonatal encephalopathy and neurodevelopmental outcomes.
Kota S, Kang S, Liu YL, Liu H, et al · · 2024 · cited 13× · PMID 39039325 · DOI 10.1038/s41390-024-03255-8
Whole-body hypothermia in mild neonatal encephalopathy: protocol for a multicentre phase III randomised controlled trial.
Garegrat R, Montaldo P, Burgod C, Pant S, et al · · 2024 · cited 5× · PMID 39026197 · DOI 10.1186/s12887-024-04935-4
EEG Spectral Power and Neurovascular Coupling as Early Predictors of Neurodevelopmental Outcome in Neonatal Hypoxic-Ischemic Encephalopathy.
Kota S, Liu YL, Bitar L, Chalak L. · · 2024 · cited 3× · PMID 40039996 · DOI 10.1109/embc53108.2024.10782342
Evaluation of neurovascular coupling during neuroprotective therapies: A single site HEAL ancillary study.
Chalak LF, Kang S, Kota S, Liu H, et al · · 2023 · cited 3× · PMID 37419079 · DOI 10.1016/j.earlhumdev.2023.105815
A Pilot Study on Dynamic Multimodal Neuromonitoring for Predicting Neurodevelopmental Outcomes in Neonatal Hypoxic-Ischemic Encephalopathy.
Kota S, Bitar L, Sepulveda P, Norasteh S, et al · · 2026 · cited 1× · PMID 40174575 · DOI 10.1159/000545599
Data-driven wavelet coherence approach to assess neurovascular coupling in neonatal hypoxic-ischemic encephalopathy.
Kota S, Norasteh S, Liu H, Bhandari EJ, et al · · 2026 · PMID 42222236 · DOI 10.1117/1.nph.13.2.025010

Verify or expand the search:

Other trials of Normothermia

Trials testing the same drug.

NCT04176471 — TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy · NA · unknown
NCT03534141 — Mild Hypothermia and Acute Kidney Injury in Liver Transplantation · NA · terminated
NCT01886222 — Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury · NA · completed

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04621279 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 8 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04621279.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing