Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 17, 2023

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2027

Conditions
Acute Kidney InjuryHIE
Interventions
DRUG

Single Dose Theophylline

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.

DRUG

Repeat Dose Theophylline

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.

Trial Locations (1)

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

All Listed Sponsors
collaborator

University of Oklahoma

OTHER

lead

Medical College of Wisconsin

OTHER