Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Medical College of Wisconsin
Study ID
NCT05853601
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • HIE

Eligibility Criteria

Sex
ALL
Age
1 Hour - 18 Hours
Healthy Volunteers
Not accepted

Interventions

  • Single Dose Theophylline — DRUG
    Subjects are given a single loading dose of theophylline, 5mg/kg IV, within 18 hours after birth. A bioequivalent dose of aminophylline, a more soluble, ethylenediamine salt of theophylline, may be substituted for theophylline. The bioequivalent dose of aminophylline is 120% of the theophylline dose.
  • Repeat Dose Theophylline — DRUG
    Subjects are given a loading dose of theophylline, 5mg/kg IV, within 18 hours of birth, and then two subsequent doses (1.2mg/kg iv) at 12 hours and 24 hours after loading dose. A bioequivalent dose of aminophylline, a more soluble, ethylenediamine salt of theophylline, may be substituted for theophylline. The bioequivalent dose of aminophylline is 120% of the theophylline dose.

Study Details

Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization. This pilot study of theophylline administration soon after birth for the prevention of kidney injury will lay the foundation for the conduct of a larger clinical trial that seeks to identify a theophylline as a novel therapy to prevent kidney injury in thousands of at-risk infants.

Key Dates

Start date
Oct 17, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Single Dose Theophylline
    Single dose of theophylline or aminophylline (5mg/kg IV) given within 18 hours after birth
  • Experimental: Repeat Dose Theophylline
    Loading dose of theophylline or aminophylline (5mg/kg IV) given within 18 hours of birth, with two subsequent doses (1.2 mg/kg IV) given at 12 and 24 hours after the loading dose
  • No Intervention: Standard treatment
    Infants cared for according to standard practice.

Primary Outcome Measure

Recruitment of patients [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Birju Shah, MD
[email protected]
405-271-5215
Natalie Goodman, BA
[email protected]
405-271-5215

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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