NCT01328808

Metabolism and Toxicity of Acetaminophen

Metabolism and Toxicity of Acetaminophen in Preterm Infants

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: John van den Anker · Academic / Other
• Sex: All
• Age: 22 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Study procedures: The decision to replace standard intravenous morphine therapy with APAP will be made by the attending neonatologist. Length of participation: 60 hours. No patient will be prescribed the medication specifically for the study purposes in the study protocol.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen/APAP	In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute

Timeline

• Start date: 2011-10-01
• Primary completion: 2021-10-01
• Completion: 2022-12-01
• First posted: 2011-04-05
• Last updated: 2022-03-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study