Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Description

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.

Conditions

Acute Kidney Injury, HIE

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Study Overview

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Study Details

Study overview

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.

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities
  • * infant with known chromosomal anomaly
  • * evidence of head trauma or skull fracture causing major intracranial hemorrhage
  • * inability to initiate hypothermia within six hours of birth
  • * attending physician unwilling to have infant participate in the study
  • * inability to obtain informed consent within 18 hours of birth

Ages Eligible for Study

1 Hour to 18 Hours

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Jeffrey Segar, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2027-04-01