RECRUITING

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

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Conditions

Acute Kidney InjuryHIE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Quick Facts

Study Start:2023-10-17
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05853601

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.

Ages Eligible for Study:1 Hour to 18 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * gestational age at birth \>= 35 weeks by best obstetrical dating
  2. * birth weight \> 1800 grams
  3. * clinical determination of HIE and treatment with hypothermia being initiated within six hours of birth according to institutional guidelines
  4. * no known congenital abnormalities involving the brain, kidneys, heart or lungs
  5. * ability to administer theophylline via intravenous route within 18 hours of birth
  1. * infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities
  2. * infant with known chromosomal anomaly
  3. * evidence of head trauma or skull fracture causing major intracranial hemorrhage
  4. * inability to initiate hypothermia within six hours of birth
  5. * attending physician unwilling to have infant participate in the study
  6. * inability to obtain informed consent within 18 hours of birth

Contacts and Locations

Study Contact

Jeffrey Segar, MD
CONTACT
414-955-8296
jsegar@mcw.edu
Kathleen Meskin, BSN
CONTACT
414-337-7171
kmeskin@mcw.edu

Principal Investigator

Jeffrey Segar, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Jeffrey Segar, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2023-10-17
Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Kidney Injury
  • HIE