Clinical TrialID 8463

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

NCT05853601

Acute Kidney Injury|HIE

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
8463
Evidence Id
8463
Core Evidence Id
8463
Source Clinical Trial Id
8461
Herb2 Clinical Trial Id
HBCT008461
Nct Id
NCT05853601
Title
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Status
Recruiting
Phase
Phase 1|Phase 2
Study Result
No
Study Condition
Acute Kidney Injury|HIE
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Intervention
DRUG: Single Dose Theophylline|DRUG: Repeat Dose Theophylline
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Prevention
Gender
All
Age
Child
Enrollment
54
Outcome Measure
Recruitment of patients, Examine the ability to recruit and enroll patients in trial. We will assess the number of eligible patients and compare that number to those actually enrolled. This ratio will inform regarding the ability to recruit patients in a larger, randomized, appropriately powered trial., 2 years
Sponsor Collaborator
Medical College of Wisconsin|University of Oklahoma
Funded By
OTHER
Location
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Other Id
PRO46949
Start Date
2023-10-17
Primary Completion Date
2026-04-01
Completion Date
2027-04-01
First Posted
2023-05-11
Results First Posted
Last Update Posted
2024-10-02
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05853601
Title Cn
Title En
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Bilingual Status
semi_complete