Metabolism and Toxicity of Acetaminophen

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or characteristics affect how APAP is handled within the preterm infant. By taking several blood and urine samples during the study, we will be able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John van den Anker
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Preterm and term neonates of both genders and all races

• a postnatal age of less than 28 days

• GA's of from 22 to less than 37 weeks

• an indwelling (peripheral or umbilical) arterial line

• a clinical indication for intravenous administration of pain relief medication

Exclusion Criteria:

• Neonates with severe asphyxia

• grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations (e.g., cleft lip and palate),

• neurological disorders

• those receiving continuous or intermittent neuromuscular blockers

• clinical or biochemical evidence of hepatic renal failure (including systemic hypoperfusion)