Hypothermia Clinical Trials

Find Hypothermia Clinical Trials Near You

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: Newborn
Healthy Volunteers: f
View:

• gestational age at birth \>= 35 weeks by best obstetrical dating

• birth weight \> 1800 grams

• clinical determination of HIE and treatment with hypothermia being initiated within six hours of birth according to institutional guidelines

• no known congenital abnormalities involving the brain, kidneys, heart or lungs

• ability to administer theophylline via intravenous route within 18 hours of birth

Locations
United States
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Jeffrey Segar, MD
jsegar@mcw.edu
414-955-8296
Backup
Elizabeth Awe, BA
eawe@childrenswi.org
414-266-6560
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2027-11
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin
Collaborators: University of Oklahoma

This content was sourced from clinicaltrials.gov

Similar Clinical Trials